Infant Orthopedics in UCLP: Effect on Feeding, Weight, and Length: A Randomized Clinical Trial (Dutchcleft)

Abstract

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 (T0 to T24); 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.