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The Use of Early Fortification in Preterm Infants

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Very premature or very low birth weight (VLBW) infants are at risk of suboptimal growth after birth, making adequate nutrition essential. Breast milk alone is insufficient to meet the nutritional needs of premature infants, so fortification is added to breast milk to support catch-up growth. Standard human milk fortification (HMF) is typically started when the feeding volume reaches 100 ml/kg/day, but research suggests that early HMF administration can increase protein intake sooner without negative effects on the infant. Early HMF administration didn't increase the incidence of food intolerance and necrotizing enterocolitis (NEC). Other studies have shown that early fortification increases the rate of early weight gain without increasing the incidence of complications. There is no research in Indonesia comparing the duration of regaining birth weight between early HMF and standard HMF. This study aims to determine the difference in the duration of regaining birth weight in very premature or VLBW infants given early HMF versus standard HMF. The research method is a prospective, randomized, double-blind preliminary study comparing early HMF administration (when feeding volume reached 30 ml/kg/day) with standard HMF (when feeding volume reached 100 ml/kg/day).
Trial Details
NCT Number NCT07861984
Lead Sponsor Universitas Indonesia
Conditions
(from sponsor)
Very Preterm Infant, Very Low Birth Weight Infants
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov