A NON-RANDOMISED TRIAL FOR EVALUATION OF THE EFFECT OF INTERVENTIONAL FEEDING PRACTICES ON GROWTH OF CLEFT LIP AND PALATE PATIENTS.
G. Jagadeesh Babu*, Chandrashekar C. **, Dr. (Mrs.) N. S. Mahanshetti M.D***
The Department of Paediatrics, J. N. Medical College, Belgaum, Karnataka - 590010, India.*, The Department of Paediatrics, J. N. Medical College, Belgaum, Karnataka - 590010, India.**, Professor & Head of the Department, Department of Paediatrics, J. N. Medical College, Belgaum. Email : jagadish_gaddam2000@yahoo.co.in ***
Abstract
Objectives: To identify the feeding problems and evaluation of the effect of interventional feeding practices on growth of cleft lip and palate patients.

Methodology: This interventional hospital based non randomized control trail was conducted at K.L.E.S Hospital, Belgaum during August 2003 to July 2004. The interventional group (22) registered at age of 2 months and followed up to age of 6 months. The control group (33) were registered at 6 months and they were selected from the patients attending cleft palate ± lip OPD at K.L.E.S Hospital, during the study period after the fulfillment of required criteria. The suggested interventional feeding practices are a) Advising specific breast feeding / top feeding techniques. b) Applying obturator (feeding plates).

Results: The feeding problems were prevalent in the interventional and control groups, with nasal regurgitation being the commonest (88.88% vs 91.66%) followed by vomiting (77.77% vs 62.51%) and choking (50.00% vs 58.33%). None of the cases with isolated cleft lip had any of the above problems. In isolated cleft lip cases there was no difference in the growth parameters with respect to weight and length. However head circumference was affected in the control group being < 5th percentile in 11.11% with none in the interventional group being affected. In babies with both cleft lip ± palate the incidence of the growth parameters being < 5th percentile were higher in the control group when compared to the interventional group which were statistically significant. Weight in interventional and control groups being 31.25% : 75.00% (p=0.0204 Fischer's Exact Test). The height parameter in interventional and control groups are 18.75%: 70.84% (p=0.0031). The length parameter in interventional and control groups are 0.62% : 37.50% (p=0.0270). The growth parameters in both the obturator and non-obturator were not statistically significant.

Conclusion: The interventional feeding practices definitely promoted all the growth parameters in babies with combined cleft palate and lip cases which were statistically significant, whereas they promoted only the head circumference in isolated cleft lip cases. The use of obturator was not associated with improved growth parameters secondary to small sample size and inherent disadvantages of its application.
Introduction
Isolated Cleft Lip, Combined Cleft Palate and Lip, Interventional Feeding Practices, Cup-spoon, Obturator Cleft lip ± palate are congenital defects that occur approximately one in every 750 births.(1) Not all infants and children with cleft palate ± lip experience significant feeding problems. Infants with cleft palate ± lip are likely to require at least some modification of feeding strategies. Feeding problems vary from minimal for an infant with an isolated cleft lip to major for infants with a cleft palate ± lip. It is vital that infants get adequate nourishment in no stressful way, beginning with the first oral feeding.(3) Hence we conducted a study to evaluate the effect of interventional feeding practices on growth of cleft lip and palate patients.
Materials and Methods
Both interventional group (22) registered at age of 2 months and followed up to age of 6 months and control group (33) registered at 6 months were selected from the patients attending cleft palate ± lip OPD at K.L.E.S Hospital, during the study period.

Exclusion criteria for both interventional and control groups were: Congenital anomalies detected clinically which are known to interfere with growth such as, congenital heart diseases, neural tube defects, gastrointestinal tract anomalies, chromosomal disorders etc.

Interventions done (only in the interventional group) are teaching specific breast feeding technique in isolated cleft lip cases: 1. To cover the gap (Cleft Lip) with thumb or breast tissue to generate adequate negative intra-oral pressure, 2. Teaching specific top feeding techniques in cleft palate + lip patients. 3. Obturators for feeding.

The growth parameters like weight, length and head circumference were recorded according to the standard guidelines.

The advice regarding the feeding was given to the mothers in their own vernacular language. Counseling was done for all the cleft palate + lip cases regarding the obturators. The babies, whose parents agreed, were fitted with the obturators by an experienced orthodontist.

The Statistical Test of significance used - Wilcoxon Rank-Sum Test (Adjusted for ties), Chi-square for Goodness of fit Test and Fischer's Exact Test.
Results
Feeding problems were prevalent in both the interventional and control groups, with nasal regurgitation being the commonest (88.88% vs 91.66%) followed by vomiting (77.77% vs 62.51%) and choking (50.00% vs 58.33%). None of the cases with isolated cleft lip had any of the above problems.

In isolated cleft lip cases, there was no difference in the growth parameters with respect to weight and length. However head circumference was affected in the control group being < 5th percentile in 11.11% with none in the interventional group

In babies with both cleft lip ± palate, the incidence of the growth parameters being < 5th percentile were higher in the control group when compared to the interventional group which were statistically significant.

Weight in interventional and control groups being 31.25%:75.00% (p=0.0204 Fischer's Exact Test). The head circumference parameter in interventional and control groups are 18.75%: 70.84% (p=0.0031). The length in the interventional and control groups are 0.62%: 37.50% (p=0.0270).

The difference in growth parameters in both the obturator and non-obturator groups were not statistically significant.
Discussion
The growth of children with cleft palate + lip, is often impaired in comparison to healthy children. Several studies describe a growth lag in either weight or height of cleft children and its a challenging task to advice them regarding the best mode of feeding. The growth lag may be either temporary or permanent.

Various explanations have been suggested for a growth lag in cleft children.
  1. Factors that slow growth during embryogenesis resulting in clefting also slow postnatal growth of the cleft child.
  2. Feeding difficulties after birth.
  3. Increased frequency of airway infections, middle ear disease, cold and intestinal infections.
  4. Cleft restoring operation.

In the present study, at the time of enrollment almost all the mothers in the cleft palate + lip interventional group were in lactation failure with top feeding their cleft babies. For hygienic reasons, most of the mothers were advised use of cup-spoon feeding which is easily accessible type of milk i.e. cow's milk with upright posture of the babies during feeding with adequate and frequent burping were advised. We measured the effectiveness of feeding on the growth parameters [weight (kg), length (cms) and head circumference (cms)]. All the isolated cleft lip cases in the interventional group were advised direct breast feeding, as it did not interfere with techniques of breast feeding.

All the isolated cleft lip cases were on direct breast feeds indicating that the defect did not interfere with techniques of direct breast feeding.(3) Most of the cleft palate + lip cases were on top feeds indicating that the defect interfered with techniques of breast feeding as initially they were tried with direct breast feeding in vain.(4) Coming to the growth comparison between the interventional and the control groups, the weight parameter in the study showed only 11.11% of isolated cleft lip cases in the control group showed failure to thrive with weight <5th percentile as compared to none in the interventional group which was not statistically significant.

This is in accordance to a study done by Pandya A. N. in 2001, where the incidence of failure to thrive in isolated cleft lip cases decreased from 09.00% in the control group to 08.00% in the interventional group although not statistically significant.(5) In the present study in combined cleft palate and lip group, majority (75.00%) in the control group showed failure to thrive with weight < 5th percentile as compared to only 31.25% of cases in the interventional group which was statistically significant.

This is in comparison to Pandya AN et al., showed incidence of failure to thrive in patients with cleft palate and lip decreased from 34.15% in control to 12.5% in the interventional group.5 Length parameter in the present study showed, isolated cleft lip cases irrespective of the interventional and the control group, majority (100% v/s 66.67%) were> 50th percentile.

In the present study, 37.50% of combined cleft palate and lip cases in the control group were < 5th percentile as compared to only 06.25% of cases in the interventional group which was statistically significant.The head circumference in the present study showed only 11.11% of isolated cleft lip cases and (70.84%) of combined cleft palate and lip cases in the control group were < 5th percentile. To the best of our knowledge, no other studies have reported about length and head circumference outcome in combined cleft palate and lip cases after the interventional feeding practices.

Our study definitely shows that the intervention done in the cases had positive correlation on the growth parameters as the observations were statistically significant. Majority (75.00%) of cases in the obturator group showed failure to thrive with weight < 5th percentile compared to only 16.66% of cases in the non-obturator group which was not statistically significant. Length of 08.33% of cases in the non-obturator group were < 5th percentile compared to none in the obturator group which was not statistically significant. Head circumference of 25.00% of cases in the obturator group were <5th percentile compared to only 16.67% of cases in the non-obturator group which was also not statistically significant.

This is in comparison to Cochrane review by Glenny AM., in 2004, where there is no statistical significant difference in growth parameters between obturator and non-obturator group.(6)
References :
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  2. Arvendons J. Craniofacial anomalies: An Interdisciplinary approach: Infant oral motor function and feeding. St Louis: Mosby-Year Book; 1992.
  3. Clarren SK, Anderson B, Wolf LS. Feeding infants with cleft lip, cleft palate or cleft lip and palate. Cleft Palate Journal. 1987; 24: 244-9.
  4. Oliver RG, Jones G. Neonatal feeding of infants born with a cleft lip and/or palate: parental perceptions of their experience in South Wales. Cleft Palate Craniofacial Journal. 1997; 34: 526-32.
  5. Pandya AN, Boorman JG. Failure to thrive in babies with cleft lip and palate. British Journal of Plastic Surgery. 2001; 54(6): 471-5.


    The reasons for the negative effect in the present study may be secondary to small sample size and inherent disadvantages of its application.

    Recommendations:

    Interventional feeding practices are essential to promote optimal growth especially in babies with cleft lip + plate. The use of obturator needs a study with larger sample size.
  6. Glenny AM, Hooper L, Shaw WC, Reilly S, Kasem S, Reid J. Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate (Cochrane Review). The Cochrane Library, Issue 4, Chichester, UK: John Wiley and Sons Ltd.; 2004.
  7. Speltz, NL, Endriga MC, Fisher PA, Moson CA. Early predictors of attachment in infants with cleft lip and/or palate. Child Development. 1997; 68: 12-25.
  8. Fogh-Anderson P, Forchhammer E. Preoperative care of cleft palate children in Denmark. Cleft Palate Journal. 1970; 7: 595-600.
  9. Seth AK, McWilliams BJ. Weight gain in children with cleft palate from birth to 2 years. Cleft Palate Journal. 1988; 25: 146-50.
  10. Jones JE, Henderson L, Avery DR. Use of a feeding obturator for infants with severe cleft lip and palate. Special Care Dentistry. 1982; 2: 116-20.
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