MedTrace Logo

Indonesia After Discharge LBW Infant HMF Supplementation Study

NCT04954807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2022-03-07

No results posted yet for this study

Summary

Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge. Human Milk Fortifier or placebo (carbohydrate only with similar calorie content) will be provided until 3 months of age. The investigators want to evaluate if the addition of HMF to mother's milk while breastfeeding LBW infants after discharge influences growth and body composition up to 3 months of age.

Conditions

  • Low; Birthweight
  • Breast Feeding, Exclusive
  • Gestational Age and Weight Conditions

Interventions

DIETARY_SUPPLEMENT

human milk fortified

HMF will be given 6 scoops a day

DIETARY_SUPPLEMENT

placebo

Placebo will be given six scoops a day

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Indonesia University

    lead OTHER

Principal Investigators

  • Yoga Devaera, MD · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2022-02-23
Completion
2022-02-25

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954807 on ClinicalTrials.gov