Vijay Tukaram Mali

NICE Advanced Neonatal Care Centre and Children’s Clinic, India

Abstract Title:

Human Milk Component Therapy in Preterm Neonates: A Randomized Controlled Trial

Biography:

Dr.Vijay Mali has completed MD in pediatrics then he did Neonatology Intensive Care Fellowship at Manipal University and John Radcliff Hospital ,Oxford University , United Kingdom . He is the founder and director of NICE Advanced Neonatal Care Centre and Children’s Clinic in Kolhapur, Maharashtra, INDIA. Published more than 10 international publications and honored with 4 Indian product Patents of Indian Government and one Australian Patent for products related to Neonatal management and breast milk storage . In Neonatology practice since last 14 years.

Research Interests:

Background: Preterm infants (28–32 weeks gestation) are at high risk of feeding intolerance, necrotizing enterocolitis (NEC), and sepsis. Human milk contains bioactive and cellular fractions that enhance gut maturation, while its high molecular weight fat fraction may overload the immature gut. We hypothesized that administering cellular and aqueous fractions of human milk (Human Milk Components, HMC) would improve clinical outcomes in preterm infants. Methods: A randomized controlled trial was conducted at NICE Advanced Neonatal Care Centre and and D.Y. Patil Medical College, India (October 2022–March 2024). Fifty-six preterm infants (28–32 weeks’ gestation) were randomized to receive HMC (n=28) or standard care (n=28). The HMC group received cellular and aqueous fractions of donor milk (25 mL/kg) in four divided doses over 72 hours from day 1 of life, along with standard colostrum and feeds. Outcomes measured included time to achieve full feeds, incidence of sepsis, antibiotic duration, and hospital stay. Results: Infants receiving HMC reached full feeds significantly earlier (median 10 vs. 18 days; p=0.03) and had fewer clinical sepsis episodes (39% vs. 64%; p=0.04) with reduced antibiotic duration (18 vs. 28 days; p=0.04). Median hospital stay was shorter (42 vs. 58 days; p=0.03). There were no significant differences in proven sepsis, NEC ≥ stage 2, IVH ≥ grade 3, or other major morbidities. Conclusion: HMC therapy significantly improved feeding tolerance and reduced sepsis and hospitalization in preterm infants. Larger multicenter double-blind trials are needed to confirm these findings. Keywords: Preterm infants, Human milk components, Gut maturation, Sepsis