Evaluation of Safety and Efficacy of Routine Addition of Hydrolyzed Protein Powder to Human Milk Fortifier Enriched Human Milk for Enteral Nutrition Compared to Conventional Human Milk Fortification in Preterm Infants: A Randomized Controlled Trial

Human breast milk especially maternal breast milk is the preferred choice for enteral nutritional support in preterm infants. Human milk based diet compared to formula feeding reduces the risk of mortality necrotizing enterocolitis NEC late onset sepsis retinopathy of prematurity bronchopulmonary dysplasia and duration of hospital stay in preterm infants. Maternal breast milk is superior to donor breast milk feeding in improving long term neurodevelopmental outcomes in preterm neonates. However there is insufficient calories major macronutrients electrolytes minerals and micronutrients in human breast milk maternal or donor to provide adequate nutritional support and to achieve optimal postnatal growth and proportionate growth in well alignment with intra uterine growth in preterm infants. Accordingly the addition of commercially available standard human milk to human breast milk is routinely being used to mitigate the risks of nutritional insufficiency and suboptimal growth in preterm neonates particularly those with very low birth weight and intra uterine growth restricted neonates as they require enhanced nutritional support to promote physical growth and neurodevelopment. Despite standardized fortification the required daily protein intake may not be met due to restrictive fluid regimen insufficient absorption and poor assimilation in preterm infants. Hydrolyzed protein powder which consists of amino acids is hypothesized to enhance protein absorption and reduce the risk of protein deficiency and promote linear growth head growth and proportionate growth without offsetting the feeding tolerance

This study focuses on preterm neonates who are often deprived of adequate protein supplementation as limited research has been conducted in India on optimized protein supplementation strategies. Based on the biological plausibility we speculate that the addition of extensively hydrolyzed protein powder to already fortified human milk with standard HMF fortification will promote short term physical growth parameters without increasing feeding intolerance in preterm infants. Furthermore this approach may support improved long term neurodevelopmental outcomes. The study aims to evaluate the short term efficacy safety and feasibility of this nutritional strategy using protein fortified powders currently available in India.