Infant orthopedics in UCLP: Effect on feeding, weight, and length: A randomized clinical trial (Dutchcleft)

Objective: To study the effects of infant orthopedics (IO) on feeding, weight, and length. Design: Prospective two-arm randomized controlled trial in three academic Cleft Palate Centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation method. Setting: Cleft Palate Centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. Patients: Infants with complete unilateral cleft lip and palate (UCLP), no other malformations. Interventions: One group (IO+) wore passive maxillary plates during the first year of life, but the other group (IO-) did not. All other interventions were the same for both groups. Main Outcome Measures: Bottle feeding velocity (mL/min) at intake, 3, 6,15, and 24 weeks (T-0 to T-24); weight-for-age, length-for-age, and weight-for-length using z scores; reference values from the Netherlands' third nationwide survey on growth. Results: Feeding velocity increased with time from 2.9 to 13.2 mL/min in the IO- group and from 2.6 to 13.8 mL/min in the IO+ group; no significant differences were found between groups. Weight-for-age, length-for-age, and weight-for-length (z scores) did not differ significantly between groups, but overall the infants with unilateral cleft lip and palate in both groups had significantly lower mean z scores for weight-for-age and height-for-age than the reference during the first 14 months, and had lower mean values for weight-for-length after soft palate closure. Conclusion: Infant orthopedics with the aim of improving feeding and consequent nutritional status in infants with unilateral cleft lip and palate can be abandoned.