Abstract
BACKGROUND: Preterm infants often face challenges with breastfeeding due to the delayed lactogenesis and feeding complications, while families, especially fathers, play a pivotal role in supporting breastfeeding. Family Integrated Lactation Management (FILM) is a structured intervention designed to address these challenges through family engagement, skill training, and personalized lactation support. OBJECTIVE: This pilot study assessed the feasibility of implementing FILM and its impact on breastfeeding outcomes among preterm infants. METHODS: A randomized controlled trial (RCT) with 30 preterm babies was conducted, assigning participants to FILM or Attention Control Group (ACG) using stratified block randomization. FILM included simulation-based parental training, lactation counseling, and family support sessions. The primary outcomes were breastfeeding rates at discharge, maternal and paternal breastfeeding self-efficacy, measured using translated and validated tools. This study is registered in Clinical Trials Registry-India (CTRI/2022/10/046204). RESULTS: FILM demonstrated higher exclusive breastfeeding rates at discharge (77%) compared to ACG (62%). Participants in the FILM group reported improved breastfeeding self-efficacy and satisfaction. The Tamil-translated lactation scales were found feasible and culturally appropriate. Recruitment and follow-up processes were successfully executed, with minor logistical challenges. CONCLUSION: FILM is a feasible and effective intervention to enhance breastfeeding outcomes among preterm infants. Its structured, family-integrated approach addresses both clinical and cultural needs, making it a promising model for lactation management for preterm babies.