Voeding na de geboorte
Uitgangsvraag
What is the best way to feed a newborn baby with a cleft palate (with or without a cleft lip / alveolus)?
Aanbeveling
Start postnataal bij voorkeur met orale voeding. Sondevoeding als primaire voeding wordt niet aangeraden.
Kies in overleg met ouders voor een geschikte geïndividualiseerde en comfortabele toedieningswijze van voeding voor een baby met een cheilo-, cheilognatho- en/of palatoschisis. Houd hierbij rekening met de volgende factoren: borstvoeding versus flesvoeding, verschillende soorten flessen en (fop)spenen, voedingshouding.
Gebruik postnataal een aangepaste fles in het geval van een palatoschisis, zoals een ‘sqeezable bottle’ or ‘feeder-driven bottle’ (Medela Special Needs Feeder) of een ‘infant-driven feeding system’ (Dr. Brown’s Specialty Feeding System).
Overweeg in het geval van een palatoschisis bij noodzaak tot het indikken van melk de Nuby Natural Touch drinkfles.
Schakel laagdrempelig de logopedist van het schisisteam (of neonatologie afdeling) in bij problemen, zoals onvoldoende intake, langdurige voedingstijd (> 30 minuten per keer) of drukplekken op het gehemelte/ neustussenschot.
Vanaf de leeftijd van 4 maanden kan gestart worden met lepelvoeding als alternatieve toedieningswijze naast borst-/flesvoeding.
Kies voor een multidisciplinaire aanpak rondom het voeden van een baby met een palatoschisis met als doel een normale groei voor het betreffende kind te bereiken.
Overwegingen
Advantages and disadvantages of the feeding methods, and quality of the evidence
One recent systematic review was found that described the effect of feeding interventions on growth and development of infants with cleft lip and/or palate. Unfortunately, only two RCT studies were included in this review that answered our clinical question and provided a limited level of evidence, due to conflicting results and small study sizes. The overall level of evidence was very low. Based on the literature it is uncertain what the effect of different feeding techniques is on patients’ growth. Furthermore no conclusions could be drawn on patients’ nutritional intake and their parents’ quality of life.
Two studies compared the use of a standard bottle and pacifier to the use of the Special Needs Feeder (squeezable). Both studies used weight, height and head circumference as outcome measures. No significant differences were found in these outcome measurements at different time points during the study. The aspect “quality of life” was experienced as better in the group with the Special Needs Feeder. However, this was not significant. Adjustments to the Special Needs Feeder were required less often than to the standard bottle (Shaw, 1999; Brine, 1994).
In two studies (Prahl, 2005; Gorstein, 1994) the possible contribution of wearing an feeding plate until the soft palate was closed, was investigated. The outcome measures were weight in relation to height, height in relation to age, and weight in relation to age (Z-score). There was no significant difference found in any of the studies. However, in Prahl's study (Prahl, 2005) a significant difference was reported for children with a complete cleft- lip-palate as compared to the normal values for Dutch children without cleft lip and palate. The children with a cleft were lighter and shorter in the first year of life as compared to non-affected Dutch children. Whether or not an feeding plate was worn, did not matter. This measured difference disappeared in the following years.
In the systematic review (Penny, 2021), two studies evaluated the possible added value of feeding plates. Although no statistical significant differences were found, the use of an feeding plate in conjunction with other interventions (i.e. specialty bottles, lactation education), seem to have added value (Goyal, 2014; Reid, 2004). A possible disadvantage of using an feeding plate is, however, the fact that it has to be manufactured (cost aspect) and regularly adjusted due to the growth of the child, which can cause stress for the baby and its parents. It requires frequent visits and can lead to problems such as fungal growth on the palate due to poor oral hygiene (Goyal, 2014).
When feeding a child with a cleft palate and an exposed vomer a pressure sore can develop on the vomer (due to repeated local pressue from the nipple of the bottle). This sore spot can certainly have a negative impact on the effectiveness of the baby's drinking behavior and the general wellbeing because of the pain this gives. Regular checks of the possible occurrence of such a pressure spot as well as an explanation to parents that changing the teat position is important to prevent this are therefore very important in these first weeks after birth.
Squeezable bottles may be more user-friendly for the parents, although current evidence does not suggest that there is a difference in squeezable and rigid bottles, regarding to normal growth (Penny, 2021).
In conclusion, few good studies were carried out to find the best way of feeding babies with cleft lip and palate and the available evidence has a low scientific level. It is not yet clear how the normal sucking- and swallowing skills develop in children with cleft lip and palate compared to the sucking- and swallowing skills in babies without cleft lip and palate (Palmer, 1993). Interventions are merely based on expert opinions, rather than on scientific evidence. Babies with cleft lip and palate are usually excluded from conducted studies about sucking skills. Palmer's studies generally assume that the sucking skills in babies with cleft lip and palate is fundamentally different, but there is no evidence for this.
More physiological functional research is needed to gain insight into the sucking- and swallowing skills of babies and children with a cleft of the palate (with or without cleft lip/alveolus). Research is also needed to provide evidence about the incidence of feeding problems with risk factors such as postoperative recovery compared to that of healthy children. The results of these studies should clarify whether and, if so, what the differences are in sucking- and swallowing skills in healthy babies and children compared to babies and children with a cleft of the palate (with or without cleft lip/alveolus). Further research is also needed, both postnatal and postoperatively, into the way in which children with a cleft lip are able to compensate for the anatomical abnormalities in the swallowing process. Additional evidence is also needed on the long-term effects of abnormal sucking- and swallowing skills on further development of the process of swallowing.
Values and preferences of patients and their parents or guardians
In the context of intraoral sensorimotor development, it is important to normalize the sucking skills, swallowing pattern and the eating pattern later on, as quickly as possible by adopting a natural diet. If tube feeding is necessary, this should be done as short as possible. Children receiving tube feeding are often more sensible around the oral cavity. Combining tube feeding with oral feeding reduces the sensibility and facilitates, for example, acceptance of teeth-brushing later on. Preferably tube feeding should be given in combination with oral nutrition or oral stimulation.
For children with a cleft lip, grasping the breast/pacifier can be difficult. This makes it more difficult for them to suck the milk out of it. In infants with a cleft of the lip (with or without the alveolus) only, breastfeeding can still be feasible. A lactation consultant can provide the parents with valuable guidance regarding different options including breastfeeding positions.
In case of a cleft palate (whether or not in combination with a cleft lip or cleft alveolus), the child is not able to suck sufficiently with normal effort. Because of the open communication between mouth and nose, no vacuum can be created. Breast feeding and the use of a regular bottle will not lead to sufficient nutrition due to the limited suction skills.
In addition, children with a cleft palate have a high risk of nasal regurgitation during feeding. A special needs feeder such as the Special Needs Feeder (Haberman) from Medela (plastic bottle with valve and special teat) will be of great help. By squeezing the teat while sucking and using the 1-2-3 system, the child's suction skills can be supported.
Mildly to moderately thick fluids (IDDSI 2-3) cannot be used in combination with the Special Needs Feeder. The Nuby (Natural Touch Softflex) teat can be used in children with reflux complaints who are prescribed thickened milk.
The Nifty cup, Paladai and spoon feeding can sometimes be used as alternative methods to breastfeeding (McKinney, 2020 and Duarte, 2016) but no convincing evidence to support this has been found in the current literature.
For children with a cleft lip and palate and their parents, it is very important that they are very well guided in the feeding process directly after birth. In case of nutritional problems, the speech and language therapist of the cleft- or neonatal team should be called for help. This speech and language therapist has knowledge of and experience with normal drinking and eating development and abnormal feeding induced by a cleft palate (with or without Cleftlip/alveolus). Furthermore, the speech therapist must be aware of the different ways of feeding and the use of the different materials and feeding positions. Indicators of quality for the feeding process are: growth (length and body weight), aerophagia, dysphagia, nasal regurgitation, amount of intake, flow, and feeding time. The confidence of parents and carertakers in good guidance and the well-being of the child and the quality of the feeding session are priorities. If there are no specific problems, another healthcare professional can take over delegated tasks from the speech and language therapist. In addition to a speech and language therapist, a psychologist or a social worker could provide valuable guidance for parents in case confidence of the parents remains an issue. More information on psychosocial guidance is provided in chapter 10.
Educational programs for parents aim to improve their knowledge about cleft conditions and appropriate feeding strategies. These programs represent a promising and cost-effective intervention as they have shown to facilitate infants growth (Penny, 2021).
We expect that with the implementation of PROMS in relation to feeding, in the near future, we can have a better insight in the feeding patterns of cleft children. These PROMS may also help parents to communicate in a structured way about the feeding problems of their cleft children. This in turn can help us as cleft care professionals to get a better understanding of the feeding difficulties in cleft children.
In conclusion, it can be stated that there is no clear preference for one way of feeding or the other; this depends on the child, the parents and the type of cleft lip and palate (Goyal, 2014). Important principles are:
- Ensure that a speech therapist is present for each cleft- or neonatal team, with knowledge of and experience with normal drinking and eating development and the effect of cleft lip and palate on this. The speech and language therapist of the cleft team must participate in the NVSCA speech therapy working group (see chapter on organization of care);
- Tailored care must be given around the nutrition of a child with a cleft lip and palate. Every parent and every child needs a different advice. The speech therapist must know and be able to apply the existing Special Needs Feeders;
- During pregnancy (after the 20-week ultrasound) and/or after birth, the cleft team provides information about the cleft lip care path. This includes information about the possibilities and impossibilities of breast and bottle feeding by the speech therapist or by a member of the cleft team from another discipline in accordance with the prescriptions of the speech therapist.
Costs/Finances
The costs of a speech therapist and the special needs feeder seem to be no problem in the Dutch setting. Also these cost do not outweight the costs in case of a hospital admission of a cleft child with feeding problems.
Acceptance, feasiblilty and implementation
For children with a cleft lip and palate, adequate nutritional supervision is necessary, so the child will be fed appropriately and an adequate oral intake is maintained. Pandya and Boorman (2001) describe a significant decrease in failure to thrive in children with cleft lip and/or palate with adequate and intensive supervision. It is important that the child is in a good nutritional state to build up resistance to infections. This is also important to be able to survive the operative phases well (Reid, 2004; Hughes, 2013).
Feeding a child with cleft lip and palate can be frustrating and stressful for the parents. When these moments of togetherness are disturbed by crying and/or restlessness in the baby, it can make the parents insecure with the risk of disturbed or less good bonding. That is why good adequate guidance is important (Miller, 2011).
Onderbouwing
Achtergrond
Feeding is a primary life need from birth. In children with cleft palate (with or without a cleft lip / alveolus), feeding can cause problems. The growth and weight gain of the baby and the bonding with parents can be disturbed as a result. Guidance by a nurse specialist and/ or a (pre-verbal) speech therapist from the cleft-team is therefore important.
Newborns use reflexes to suck, swallow and breathe during the first few weeks. An efficient sucking motion is achieved by creating negative intra-oral pressure with good nipple/teat enclosure and soft palate elevation (Reid, 2004). This is done by a rhythmical movement of tongue and lower jaw, closing the nasopharynx and increasing the intra-oral space. A positive pressure is thereby applied to the nipple/teat with the lips, facilitating milk transfer out of the nipple/teat. Together with the suction, this makes efficient feeding possible.
In babies born with a lip alveolus cleft only (with an intact palate), drinking from the breast or bottle usually proceeds with little or no problems. If necessary, a small adjustment in position, teat, or support of the base of the mouth and lips will usually suffice.
Babies born with a cleft palate only, or a congenitally short palate, are at risk for developing feeding problems. This also applies to babies with a cleft lip, alveolus and palate. When a cleft palate exists, the baby is generally unable to close off the oral cavity from the nasal cavity. As a result, the baby cannot effectively create a sufficient vacuum during sucking. The vacuum stabilizes the nipple or teat and is necessary to actively obtain (breast) milk from the breast/teat (Watson, 2001; Sell, 2001; Grunwell, 2001).
Research shows that a less efficient sucking pattern is present in children with nonsyndromic unilateral complete cleft lip, alveolus and/or palate (compared to peers without cleft) (Maserai, 2007; Besell, 2011). This can lead to longer feeding time, and increased fatigue. Furthermore, it appears that these infants with a cleft require proportionally more energy, to ingest a relatively small amount of milk than their healthy peers (Sphrintzen, 1995; Bardach, 1995).
The main goal of nutrition in newborns is normal weight gain and length growth. In this chapter, we try to provide the most appropriate forms of administration of nutrition (milk) in newborns with cleft palate (with or without a cleft lip / alveolus). To monitor feeding, the following quality parameters can be taken into account: growth and length of the child, aerophagia, dysphagia, nasal regurgitation, amount of intake, flow, feeding time and parental confidence. The well-being of the child and the quality of the feeding session for a child and its parents is paramount. The various special needs bottles: 'sqeezeable bottles' or 'feeder-driven' bottles (Medela Special Needs Feeder) and 'infant-driven feeding systems' (Dr. Brown's Specialty Feeding System) and alternative feeding systems such as syringe, cupfeeding and spoonfeeding will be examined for this chapter. The use of feeding plates and educational programs for parents will also be evaluated.
Conclusies
1. Amount of feeding intake (crucial)
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- GRADE |
The level of evidence regarding the outcome measure amount of feeding intake was not assessed due to lack of studies.
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2. Patient’s growth (length and weight) (crucial)
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Very low GRADE |
The evidence is very uncertain about the effect of a rigid bottle on length and weight after 3, 6, 12 and 18 months when compared with a squeezable bottle in patients with cleft lip and/or palate.
Sources: Shaw (1999) and Brine (1994) |
3. Parents’ quality of life (important)
|
- GRADE |
The level of evidence regarding the outcome measure parents’ quality of life was not assessed due to lack of studies.
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Samenvatting literatuur
Description of studies
Penny (2021) describes a systematic review including RCT studies evaluating the effect of feeding interventions on growth and development of infants with cleft lip and/or palate, published between inception and May 2021. Two RCTs (n=138) included in this systematic review answered the clinical question of this chapter. Both RCTs compared squeezable with rigid bottles (Shaw, 1999; Brine, 1994). Two other RCTs studied the effect of a maxillary plate, which was beyond the scope of this chapter (Massarei, 2007; Prahl, 2005). Other RCTs in the study of Penny (2021) did not provide follow-up data on post-natal feeding for at least 12 months.
- Brine (1994) included 37 babies with cleft palate or cleft lip and palate, prior to closure. Babies in the intervention group were fed with a squeezable nurser (n=18), babies in the control group were fed with a rigid bottle with cross-cut nipple (n=13). All babies with cleft lip and palate received an intraoral maxillary obturator, regardless of treatment group. Relevant outcome measures include growth in length and weight. The follow-up was 18 months.
- Shaw (1999) included 101 babies with cleft lip (n=25), cleft palate (n=31) or cleft lip and palate (n=45). Babies in the intervention group were fed with a squeezable bottle with Nuk orthodontic teat (n=49), babies in the control group were fed with a rigid bottle with Nuk orthodontic teat (n=52). Relevant outcome measures include growth in length and weight. The follow-up was 12 months.
Penny (2021) provides a narrative description of the results of each included trial and refers to the Cochrane systematic review by Bessell (2011) in which pooled analyses of these two trials are published.
Results
1. Amount of feeding intake (crucial)
The outcome amount of feeding intake was not reported in the included studies.
Level of evidence of the literature
The level of evidence regarding the outcome measure amount of feeding intake was not assessed due to lack of studies.
2. Patient’s growth (both length and weight) (crucial)
Length was described in the studies of Shaw (1999) and Brine (1994).
In the RCT of Brine (1994), data for length was provided for timepoints 6 and 18 months.
At 6 months, mean length in the rigid bottle group was 64.5 cm (SD 1.8, n=13). Mean length in the squeezable bottle group was 63.5 cm (SD: 2.5, n=18). Mean difference between the two groups was 1.00 cm (95% CI: -0.51 to 2.51), favoring the rigid bottle group.
At 18 months, mean length in the rigid bottle group was 80.6 cm (SD 2.9, n=13). Mean length in the squeezable bottle group was 81.7 cm (SD: 2.4, n=18). Mean difference between the two groups was 1.90 cm (95% CI: -0.03 to 3.83), favoring the rigid bottle group.
In the RCT of Shaw (1999), length was measured after 13 weeks, 26 weeks and 52 weeks.
At 13 weeks, mean length in the rigid bottle group was 55.3 cm (SD 2.04, n=52). Mean length in the squeezable bottle group was 55.3 cm (SD: 2.25, n=49). Mean difference between the two groups was 0.00 cm (95% CI: -0.84 to 0.84).
At 26 weeks, mean length in the rigid bottle group was 66.7 cm (SD 2.5, n=51). Mean length in the squeezable bottle group was 66.8 cm (SD: 2.18, n=49). Mean difference between the two groups was -0.10 cm (95% CI: -1.02 to 0.82), due to more length in the squeezable bottle group.
At 52 weeks, mean length in the rigid bottle group was 74.8 cm (SD 3.03, n=50). Mean length in the squeezable bottle group was 75.1 cm (SD: 2.33, n=49). Mean difference between the two groups was -0.30 cm (95% CI: -1.36 to 0.76), due to more length in the squeezable bottle group.
Weight was described in the studies of Shaw (1999) and Brine (1994).
In the RCT of Brine (1994), weight was measured after 6 and 18 months. After 6 months, mean weight in the rigid bottle group was 6.98 kg (SD: 0.76, n=13). Mean weight in the squeezable bottle group was 6.86 kg (SD: 0.36, n=18). Mean difference between the two groups was 0.12 kg (95% CI: -0.33 to 0.57), favoring the rigid bottle group.
After 18 months, mean weight in the rigid bottle group was 10.6 kg (SD: 1.1, n=13). Mean weight in the squeezable bottle group was 10.14 kg (SD: 0.7, n=18). Mean difference between the two groups was 0.46 kg (95% CI: -0.22 to 1.14), favoring the rigid bottle group.
In the RCT of Shaw (1999), weight was measured after 13 weeks, 26 weeks and 52 weeks.
At 13 weeks, mean weight in the rigid bottle group was 4.38 kg (SD: 0.51, n=52). Mean weight in the squeezable bottle group was 4.43 kg (SD: 0.51, n=49). Mean difference between the two groups was -0.05 kg (95% CI: -0.25 to 0.15), due to a higher weight in the squeezable bottle group.
At 26 weeks, mean weight in the rigid bottle group was 7.04 kg (SD: 1.56, n=51). Mean weight in the squeezable bottle group was 7.38 kg (SD: 0.73, n=49). Mean difference between the two groups was -0.34 kg (95% CI: -0.81 to 0.13), due to a higher weight in the squeezable bottle group.
At 52 weeks, mean weight in the rigid bottle group was 9.22 kg (SD: 1.22, n=50). Mean weight in the squeezable bottle group was 9.64 kg (SD: 1.06, n=49). Mean difference between the two groups was -0.42 kg (95% CI: -0.87 to 0.03), due to a higher weight in the squeezable bottle group.
Level of evidence of the literature
The level of evidence regarding the outcome measures length and weight at any timepoint started at high because it was based on randomized controlled trials, but was downgraded by three levels because of conflicting results (inconsistency, -1) and limited number of included patients (imprecision, -2). The final level is very low.
3. Parents’ quality of life (important)
The outcome parents’ quality of life was not reported in the included studies.
Level of evidence of the literature
The level of evidence regarding the outcome measure parents’ quality of life was not assessed due to lack of studies.
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question: What is the most efficient feeding technique for normal weight-gain in patients with cleft lip, alveolus and/or palate?
In the 2021 update of this guideline, post-operative feeding is evaluated in a separate module (module 5, postoperative nutritional care for isolated clefts of the lip alveolus and or palate).
P: patients with cleft lip, alveolus and/or palate (postnatal)
I: 1) feeding technique;
2) feeding position;
3) consistency of nutrition (Special Needs Feeder, breastfeeding, tube feeding, spoon feeding, finger feeding, post-natal counseling, feeding-system (both bottle and nipple)).
C: other method of feeding
O: amount of feeding intake, patient’s growth (both length and weight), parents’ quality of life (measured at 3, 6 and 12 months)
Relevant outcome measures
The guideline development group considered amount of feeding intake and newborn’s growth (both length and weight) as critical outcome measures for decision making, and parents’ quality of life as an important outcome measure for decision making.
A priori, the working group did not define the outcome measures listed above but used the definitions used in the studies.
The working group did not define the minimal clinically (patient) important difference for the different continuous outcome measures. Therefore, the following criteria of the minimally important difference were used for the continuous outcome measures; Standardized mean difference (SMD=0.2 (small); SMD=0.5 (moderate); SMD=0.8 (large)). No a priori criteria were set for the dichotomous outcome measures because it largely depends on its context.
Search and select (Methods)
A previous systematic search was performed for the 2018 edition of the guideline in the databases of Medline (through OVID) Embase and the Cochrane Library between 1980 and November 5th, 2014. The initial search identified 65 references of which 17 were assessed on full text. After assessment of full text, nine studies were excluded, and eight studies were included. To update the previous search the databases Medline (via OVID) and Embase via Embase.com were searched with relevant search terms until November 15th, 2021. The detailed search strategy is depicted under the tab Methods. The updated systematic literature search on postnatal feeding resulted in 249 hits. Studies were selected based on the following criteria. Studies that investigated patients with cleft lip, alveolus and/or palate were selected if they compared two different feeding methods. The feeding interventions had to be studied immediately after birth. Data on effect sizes or primary data had to be available for at least one of the outcomes of interest: amount of feeding intake, patient’s growth (both length and weight), parents’ quality of life. Follow-up time had to be at least 12 months.
Eleven studies were initially selected based on title and abstract screening. After reading the full text, ten studies were excluded (see the table with reasons for exclusion under the tab Methods), and one study was included.
Results
One study was included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.
Referenties
- Bessell A, Hooper L, Shaw WC, Reilly S, Reid J, Glenny AM. Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD003315. doi: 10.1002/14651858.CD003315.pub3. PMID: 21328261; PMCID: PMC7144736.
- Brine EA, Rickard KA, Brady MS, Liechty EA, Manatunga A, Sadove M, Bull MJ. Effectiveness of two feeding methods in improving energy intake and growth of infants with cleft palate: a randomized study. J Am Diet Assoc. 1994 Jul;94(7):732-8. doi: 10.1016/0002-8223(94)91938-0. PMID: 8021413.
- Duarte GA, Ramos RB, Cardoso MC. Feeding methods for children with cleft lip and/or palate: a systematic review. Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):602-9. doi: 10.1016/j.bjorl.2015.10.020. Epub 2016 Mar 2. PMID: 26997574.
- Goyal M, Chopra R, Bansal K, Marwaha M. Role of obturators and other feeding interventions in patients with cleft lip and palate: a review. Eur Arch Paediatr Dent. 2014 Feb;15(1):1-9. doi: 10.1007/s40368-013-0101-0. Epub 2014 Jan 15. PMID: 24425528.
- Hughes J, Lindup M, Wright S, Naik M, Dhesi R, Howard R, Sommerlad B, Kangesu L, Sury M. Does nasogastric feeding reduce distress after cleft palate repair in infants? Nurs Child Young People. 2013 Nov;25(9):26-30. doi: 10.7748/ncyp2013.11.25.9.26.e324. PMID: 24200186.
- Masarei AG, Wade A, Mars M, Sommerlad BC, Sell D. A randomized control trial investigating the effect of presurgical orthopedics on feeding in infants with cleft lip and/or palate. Cleft Palate Craniofac J. 2007 Mar;44(2):182-93. doi: 10.1597/05-184.1. PMID: 17328643.
- M McKinney C, Balakrishnan U, Ninan B, Glass R, Cunningham M, Murthy J. A Comparative Study of Two Infant Feeding Tools: The Nifty Cup and The Paladai. Indian J Pediatr. 2020 Jul;87(7):505-511. doi: 10.1007/s12098-020-03237-8. Epub 2020 Feb 22. PMID: 32088911.
- Miller CK. Feeding issues and interventions in infants and children with clefts and craniofacial syndromes. Semin Speech Lang. 2011 May;32(2):115-26. doi: 10.1055/s-0031-1277714. Epub 2011 Sep 26. PMID: 21948638.
- Pandya AN, Boorman JG. Failure to thrive in babies with cleft lip and palate. Br J Plast Surg. 2001 Sep;54(6):471-5. doi: 10.1054/bjps.2001.3618. PMID: 11513506.
- Penny C, McGuire C, Bezuhly M. A Systematic Review of Feeding Interventions for Infants with Cleft Palate. Cleft Palate Craniofac J. 2021 Oct 29:10556656211051216. doi: 10.1177/10556656211051216. Epub ahead of print. PMID: 34714161.
- Prahl C, Kuijpers-Jagtman AM, Van 't Hof MA, Prahl-Andersen B. Infant orthopedics in UCLP: effect on feeding, weight, and length: a randomized clinical trial (Dutchcleft). Cleft Palate Craniofac J. 2005 Mar;42(2):171-7. doi: 10.1597/03-111.1. PMID: 15748108.
- Reid J. A review of feeding interventions for infants with cleft palate. Cleft Palate Craniofac J. 2004 May;41(3):268-78. doi: 10.1597/02-148.1. PMID: 15151444.
- Shaw WC, Bannister RP, Roberts CT. Assisted feeding is more reliable for infants with clefts--a randomized trial. Cleft Palate Craniofac J. 1999 May;36(3):262-8. doi: 10.1597/1545-1569_1999_036_0262_afimrf_2.3.co_2. PMID: 10342616.
Evidence tabellen
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Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C)
|
Follow-up |
Outcome measures and effect size |
Comments |
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Penny 2021
[individual study characteristics deduced from [1st author, year of publication ]]
PS., study characteristics and results are extracted from the SR (unless stated otherwise) |
SR and meta-analysis of RCTs
Literature search up to October 2010
A: Brine 1994 B: Shaw 1999
Study design: RCT [parallel / cross-over],
Setting and Country: United Kingdom
Source of funding: Non-commercial
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Inclusion criteria SR: 1) randomized controlled trials using either true or quasi methods of random allocation 2) patients: babies born with cleft lip or palate up to the age of 6 months from term 3) intervention: modified bottles, cups, spoons, pumps, positions, techniques and/or teats (to supplement breastfeeding or instead of breastfeeding), obturating plates or maternal advice or support. Any intervention could be compared to any other or to unmodified equipment or advice. 4) Outcomes: primary: growth. Secondary: development, parental satisfaction
Exclusion criteria SR: 1) patients: babies born with syndromes
2 studies included
Important patient characteristics at baseline: Number of patients; characteristics important to the research question and/or for statistical adjustment (confounding in cohort studies); for example, age, sex, bmi, ...
N, mean age A: 37, 15 days B: 101, from birth
Sex: A: 57% Male B: 58% Male
Groups comparable at baseline? Unclear
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Describe intervention:
A: squeezable nurser B: squeezable bottle with Nuk orthodontic teat
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Describe control:
A: rigid bottle with standard cross-cut nipple B: rigid bottle with Nuk orthodontic teat
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End-point of follow-up:
A: 18 months B: 12 months of age
For how many participants were no complete outcome data available? (intervention/control) A: no drop-outs listed, no reasons for attrition given B: dropouts listed and described in full
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Length
Difference between group in cm
A: Brine (1994) Mean difference: 1.90 cm (95% CI: -0.03 to 3.83), favouring the rigid bottle group.
B: Shaw (1999) Mean difference: -0.30 cm (95% CI: -1.36 to 0.76), favouring squeezable bottle.
Weight Defined as. Difference in Increase in weight in kg
A: Brine (1994) Mean difference: 0.46 kg (95% CI: -0.22 to 1.14), favouring rigid bottle.
B: Shaw (1999) Mean difference: -0.42 kg (95% CI: -0.87 to 0.03), favouring squeezable bottle.
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Facultative:
Brief description of author’s conclusion
There is a moderate very low level of evidence that for using squeezable bottles results in a similar weight gain and height as feeding from compared to rigid bottles in infants with cleft lip and/or palate There is a low level of evidence that in infants with cleft lip and/or palate breastfeeding results in a higher weight gain when compared to spoon-feeding. There is a moderate level of evidence that in infants with cleft lip and/or palate the use of a feeding plate results in a similar weight gain and height as not using a feeding plate.
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Risk of bias table for intervention studies (randomized controlled trials; based on Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University)
Research question: What is the most efficient feeding technique for normal weight-gain in patients with cleft lip, alveolus and/or palate?
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Study reference
(first author, publication year) |
Was the allocation sequence adequately generated?
Definitely yes Probably yes Probably no Definitely no |
Was the allocation adequately concealed?
Definitely yes Probably yes Probably no Definitely no |
Blinding: Was knowledge of the allocated interventions adequately prevented?
Were patients blinded?
Were healthcare providers blinded?
Were data collectors blinded?
Were outcome assessors blinded?
Were data analysts blinded?
Definitely yes Probably yes Probably no Definitely no |
Was loss to follow-up (missing outcome data) infrequent?
Definitely yes Probably yes Probably no Definitely no |
Are reports of the study free of selective outcome reporting?
Definitely yes Probably yes Probably no Definitely no |
Was the study apparently free of other problems that could put it at a risk of bias?
Definitely yes Probably yes Probably no Definitely no |
Overall risk of bias If applicable/necessary, per outcome measure
LOW Some concerns HIGH
|
|
Brine, 1994 |
Unclear;
Reason: No information for sequence generation was provided. |
Unclear;
Reason: No information for concealment was provided. |
Defenitely no;
Reason: No blinding was reported for any party involved in the trial. |
Unclear;
Reason: No information provided for drop-outs. |
Probably yes;
Reason: All relevant pre-defined outcomes were reported |
Probably yes;
Reason: No other problems reported. |
Some concerns (all outcomes) |
|
Shaw, 1999 |
Probably yes;
Reason: randomization-list was provided by trial statistician |
Defenitely yes;
Reason: Opaque envelopes were used |
Definitely no
Reason: No blinding was reported for any party involved in the trial. |
Probably yes
Reason: Loss to follow-up was infrequent and described. |
Probably yes
Reason: All relevant pre-defined outcomes were reported |
Probably yes;
Reason: No other problems reported. |
Some concerns (all outcomes)
|
Table of excluded studies
|
Author and year |
Reason for exclusion |
|
Burca 2016 |
Narrative review (wrong study design) |
|
De Vries 2013 |
Observational study (wrong study design) |
|
Duarte 2015 |
Less complete than Penny 2021 |
|
Goyal 2014 |
Earlier search than Penny 2021 |
|
Kaye 2017 |
Retrospective chart review (wrong study design) |
|
Madhoun 2021 |
Cross-sectional cohort (wrong study design) |
|
McKinney 2020 |
Observational study (wrong study design) |
|
Murthy 2020 |
Follow-up to 6 months (follow-up too short) |
|
Ravi 2015 |
prospective cohort (wrong study design) |
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 30-09-2022
Laatst geautoriseerd : 30-09-2022
Geplande herbeoordeling :
Algemene gegevens
The revision of this guideline module was supported by Knowledge Institute Federation of Medical Specialists (www.kennisinstituut.nl) and was financed by the Quality Foundation of the Dutch Medical Specialists (SKMS). The funding organization did not have any influence on the content of the guideline in any way.
Samenstelling werkgroep
A multidisciplinary working group was appointed by the Dutch Society for Plastic and Reconstructive Surgery in October 2021 to update the existing module on feeding after birth for newborns with for clefts of the lip and/or palate. The original guidelines were initiated by the Dutch Society for Plastic and Reconstructive Surgery and this Society remains responsible for the revisions. The working group updated the chapter for prenatal feeding for clefts of the lip, alveolus, and/or palate. The working group consisted of representatives from relevant specialties involved in the care for patients with cleft lip, alveolus and/or palate. Members were mandated by their professional organizations. The working group consisted of a mix of new members and members, who worked on the 2021 edition as well. The group worked on the update of the guideline for one year. The working group is responsible for the full text of this guideline.
- Dr. A.B. Mink van der Molen, MD, plastic surgeon, Universitair Medisch Centrum Utrecht, (chairman), NVPC
- Drs. F. Bierenbroodspot, MD, Oral and maxillofacial surgeon, Isala, Zwolle, NVMKA
- Dr. M.E.L. Nienhuijs, MD, Oral and maxillofacial surgeon, Radboud University Medical Center, NVSCA
- Mw. E Kerkhofs, speech and language therapist, Radboud University Medical Center, NVLF
With methodological support of
- Drs. A.A. Lamberts, senior advisor, Knowledge Institute Federation of Medical Specialists
- Drs. B. Vogelaar, junior advisor, Knowledge Institute Federation of Medical Specialists
Belangenverklaringen
According to the KNMG-code, all members of the working group have declared in writing if, in the last five years, they have held a financially supported position with commercial businesses, organisations or institutions that may have a connection with the subject of the guidelines. Enquiries have also been made into personal financial interests, interests pertaining to personal relationships, interests pertaining to reputation management, interests pertaining to externally financed research, and interests pertaining to valorisation of knowledge. These Declarations of Interest can be requested from the secretariat of the Knowledge Institute of Medical Specialists. See below for an overview.
|
Member |
Profession |
Side jobs |
Declared conflicting interests |
Actions |
|
Dr. A.B. Mink van der Molen |
plastic surgeon, |
None |
None |
No actions |
|
Drs. F. Bierenbroodspot |
Oral and maxillofacial surgeon |
Working Group Esthetische Aangezichtschirurgie |
None |
No actions |
|
Dr. M. Nienhuijs |
Oral and maxillofacial surgeon |
Boardmember NVSCA |
None |
No actions |
|
Mw. E. Kerkhofs |
Speech and language therapist |
Logopedist KNO/ cleft-team, craniofacial team, paediatric audiology: speech-, language-, audiology |
None |
No actions |
Inbreng patiëntenperspectief
Patients were represented by Schisis Nederland. Schisis Nederland is an independent organization representing patients with CLA/Psand their parents in the Netherlands. Representatives from Schisis Nederland participated in the working group. The concept guideline module was presented to Schisis Nederland for their comments.
Implementatie
Guideline implementation and practical applicability of the recommendations was taken into consideration during various stages of guideline development. Factors that may promote or hinder implementation of the guideline in daily practice were given specific attention. The guideline is distributed digitally among all relevant professional groups. The guideline can also be downloaded from the Dutch Society for Plastic and Reconstructive Surgery website: www.nvpc.nl, and the guideline website: www.richtlijnendatabase.nl. The implementation table can be found in the related products.
Werkwijze
AGREE
The guideline has been drafted in accordance with the requirements outlined in the ‘Guidelines 2.0’ report of the Guideline Advisory Committee of the Council on Science, Education and Quality (WOK). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (Brouwers, 2010), an instrument designed to assess the quality of guidelines with broad international support (Brouwers, 2010). The development of a evidence-based guideline module is described step-by-step in “Ontwikkeling van Medisch Specialistische Richtlijnen” of Knowledge Institute for Medical Specialists.
Inventory of the problem areas
During the preparation phase the working group used an inventory to find the problem areas. A report of this inventory can be found in the related products.
Primary questions and outcome measures
Based on the outcomes of the bottleneck analysis, the president and advisor formulated draft primary questions. These were discussed and defined together with the working group. Subsequently, the working groupdetermined which outcome measures were relevant for the patient for each primary question, examining both desired and undesirable effects. The working groupvaluated these outcomes based on their relative importance as crucial, important and unimportant.
Literature search and selection strategy
Specific search terms were used to identify published scientific studies related to each individual primary question in electronic databases like Medline, Cochrane, and Embase. Additionally, the references of the selected articles were screened for additional relevant studies. Studies offering the highest level of evidence were sought out first. Members of the working group selected articles identified by the search based on predetermined criteria. Theselected articles were used to answer the primary question. The searched databases, the search string or terms used during the search and selection criteria applied are listed in the module for each individual primary question.
Quality assessment of individual studies
Individual studies were assessed systematically based on predefined methodological quality criteria in order to assess the risk of biased study results. These assessments may be found in the column ‘Study quality assessment’ in an evidence table.
• AMSTAR - for systematic reviews.
• Cochrane - for randomized controlled trials.
• ACROBAT-NRS - for observational studies.
• QUADAS II - for diagnostic studies.
Summary of the literature
The relevant study results from all selected articles were presented clearly in evidence tables. The key findings from the literature are described in the literature summary. If studies were sufficiently similar in design, data were also summarized quantitatively (meta-analysis) using Review Manager 5.
Assessment of the level of scientific evidence
With regard to intervention questions, the level of scientific evidence was determined using the GRADE method. GRADE is short for ‘Grading Recommendations Assessment, Development and Evaluation’ (see http://www.gradeworkinggroup.org/)
GRADE distinguishes four grades of quality of evidence, i.e. high, moderate, low and very low. These grades indicate the degree of confidence in the conclusions in the literature ((Schünemann, 2013; Hultcrantz, 2017).
|
GRADE |
Definition |
|
High |
|
|
Moderate |
|
|
Low |
|
|
Very low |
|
According to the GRADE methodology the clinical decision threshold should play an important role in assessing the level of evidence (grading) in guidelines (Hultcrantz, 2017). To set the threshold all critical outcomes, and the considerations should be determined. The clinical decision threshold is not exactly the same as the Minimal Clinically Important Difference (MCID). In situations in which an intervention has no important disadvantages and low costs, the clinical decision threshold with regard to the efficiency of an intervention can be lower (closer to zero/ no effect) than MCID (Hultcrantz, 2017).
Formulation of conclusions
For interventions, the conclusion does not refer to one or more articles, but is drawn based on the body of evidence. The working group looked at the net benefits of each intervention. This was done by determining the balance between favourable and unfavourable effects for the patient.
With regard to questions about the value of diagnostic tests, harm or adverse effects, aetiology and prognosis, the scientific evidence is summarized in one or more conclusions, listing the level of evidence for the most relevant data.
Considerations
When making recommendations, scientific evidence was considered together with other key aspects, such as expertise of the group members, patient preferences, costs, availability of facilities and/or organizational aspects. Insofar as they are not part of the systematic literature review, these aspects are listed under ‘Considerations’. The considerations are written using a structured format based on the evidence-to-decision framework of the international GRADE Working Group, and part of the GRADE methodology (Alonso-Coello, 2016a; Alonso-Coello 2016b).
Formulation of recommendations
Recommendations provide an answer to the primary question and are based on the best scientific evidence available and the most important considerations. The level of scientific evidence and the importance given to considerations by the working group jointly determine the strength of the recommendation. In accordance with the GRADE method, a low level of evidence for conclusions in the systematic literature review does not rule out a strong recommendation, while a high level of evidence may be accompanied by weak recommendations (Agoritsas, 2017; Neumann, 2016). The strength of the recommendation is always determined by weighing all relevant arguments.
Preconditions (Organisation of care)
In the analysis of problem areas, the organisation of care (all those aspects that are preconditions for the provision of care) were explicitly taken into account. These aspects include coordination, communication, materials, financial means, work force and infrastructure. Preconditions that are relevant to the answering of a specific clinical question are part of the considerations related to that specific question.
Knowledge gaps
During the development of this guideline, systematic searches were conducted for research contributing to answering the primary questions. For each primary question, the working group determined whether (additional) scientific research is desirable.
Commentary and authorization phase
The draft guideline was submitted to the (scientific) organizations involved for comment. The guideline was also submitted to the following organizations for comment: Dutch College of General Practitioners (NHG), Healthcare Insurers Netherlands (ZN), The Dutch Healthcare Authority (NZA), the National Health Care Institute (ZINL), the Health Care Inspectorate (IGJ), Dutch Organisation of Hospitals (NVZ), Dutch Federation of Academic Hospitals (NFU), Dutch Organisation of Independent Clinics (ZKN), the Netherlands Patients Federation, Dutch Organisation of nurses and caregivers (V&VN), Dutch Association of Physician Assistants, and Collaborating Top Clinical Training Hospitals (STZ). Comments were collected and discussed with the working group. The draft guideline was updated and finalized by the working group based on the comments. The final guideline was submitted for authorization to the (scientific) organizations involved and authorized or approved by them.
Literature
Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.
Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.
Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.
Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348.
Hultcrantz M, Rind D, Akl EA, et al. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. PubMed PMID: 28529184.
Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwalitieit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html.
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.
Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106-10. doi: 10.1136/bmj.39500.677199.AE. Erratum in: BMJ. 2008;336(7654). doi: 10.1136/bmj.a139. PubMed PMID: 18483053.
Wessels M, Hielkema L, van der Weijden T. How to identify existing literature on patients' knowledge, views, and values: the development of a validated search filter. J Med Libr Assoc. 2016 Oct;104(4):320-324. PubMed PMID: 27822157; PubMed Central PMCID: PMC5079497.
Zoekverantwoording
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