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COMPLETED
NCT07861984
NA

The Use of Early Fortification in Preterm Infants

Sponsor: Universitas Indonesia

View on ClinicalTrials.gov

Summary

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).

Official title: Early Fortification to Shorten Birth Weight Recovery Time in Very Preterm or Very Low Birth Weight Infants

Key Details

Gender

All

Age Range

28 Weeks - 32 Weeks

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2024-11-10

Completion Date

2025-06-30

Last Updated

2026-10-06

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Early Fortification

In the early fortification group, 1 sachet of HMF was added to 30 ml of breast milk for the first 24 hours. If the feeding tolerance was good, 1 sachet of HMF was then mixed into 25 ml of breast milk.

DIETARY_SUPPLEMENT

Standard Fortification

In the standard fortification group, 1 sachet of HMF was mixed into 25 ml of breast milk starting from the first day of HMF administration.

Locations (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia