Surgeon's and Caregivers' Appraisals of Primary Cleft Lip Treatment with and without Nasoalveolar Molding: A Prospective Multicenter Pilot Study

Background: Despite the increasing use of nasoalveolar molding in early cleft treatment, questions remain about its effectiveness. This study examines clinician and caregiver appraisals of primary cleft lip and nasal reconstruction with and without nasoalveolar molding in a nonrandomized, prospective, multicenter study. Methods: Participants were 110 infants with cleft lip/palate (62 treated with and 48 treated without nasoalveolar molding) and their caregivers seeking treatment at one of six high-volume cleft centers. Using the Extent of Difference Scale, standard photographs for a randomized subset of 54 infants were rated before treatment and after surgery by an expert clinician blinded to treatment group. Standard blocked and cropped photographs included frontal, basal, left, and right views of the infants. Using the same scale, caregivers rated their infants' lip, nose, and facial appearance compared with the general population of infants without clefts before treatment and after surgery. Multilevel modeling was used to model change in ratings of infants' appearance before treatment and after surgery. Results: The expert clinician ratings indicated that nasoalveolar molding-treated infants had more severe clefts before treatment, yet both groups were rated equally after surgery. Nasoalveolar molding caregivers reported better postsurgery outcomes compared with no-nasoalveolar molding caregivers (p < 0.05), particularly in relation to the appearance of the nose. Conclusions: Despite having a more severe cleft before treatment, infants who underwent nasoalveolar molding were found by clinician ratings to have results comparable to those who underwent lip repair alone. Infants who underwent nasoalveolar molding were perceived by caregivers to have better treatment outcomes than those who underwent lip repair without nasoalveolar molding. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.