"Feeding Effectiveness of Nasoalveolar Molding Appliances Made with Polymethyl Methacrylate vs. Polyamide in Newborns with Unilateral Cleft Lip and Palate: A Randomized Controlled Trial"

Authors: sangeetha morekonda gnaneswar, nirmala anandan

DOI: 10.18231/j.jco.9933.1463658578

Keywords: Cleft lip and palate, nasoalveolar molding, feeding efficiency, polymethyl methacrylate, polyamide, randomized controlled trial.

Abstract: Background: Infants with cleft lip and palate face feeding challenges due to anatomical disruptions, leading to complications like nasal regurgitation, choking, and poor nutrition. Nasoalveolar molding (NAM) appliances, traditionally made from polymethyl methacrylate (PMMA), reduce the severity of cleft before surgery, help seal the oronasal opening and improve feeding. PMMA’s rigidity limits adaptability, potentially reducing feeding efficiency. Polyamide, a crystalline polymer with higher flexibility and reduced thickness may provide a better anatomical adaptation, enhancing feeding performance. Aim:To evaluate the feeding effectiveness of NAM appliances made from PMMA versus polyamide in newborns with unilateral cleft lip and palate. Materials and Methods:A randomized controlled trial was conducted from July 2021 to June 2024 at two hospitals in South India with an initial sample size of 100 with two groups: Group A(PMMA NAM,n=50) and Group B(Polyamide NAM, n=50). Block randomization ensured balanced allocation, and investigators were blinded. After attrition, the final sample size was 80 (40 per group). NAM appliances were delivered and activated biweekly. Feeding effectiveness was assessed via bottle-feeding volumes and weight gain at baseline (T0), post-intervention(T1), Week 4 (T2), and Week 8 (T3). Results: No significant differences in feeding volumes were observed before appliance delivery. Post-intervention, Group B exhibited a significant increase in feeding volume on Day 3 (p=0.001) and across the three-day average (p=0.040). While Week 4 differences were not statistically significant (p=0.103), Group B showed superior feeding efficiency by Week 8 (p=0.045). Weight analysis showed, a significant difference by T1 (