Indonesia After Discharge LBW Infant HMF Supplementation Study

Not Applicable

Completed

• Conditions: Low; Birthweight; Gestational Age and Weight Conditions; Breast Feeding, Exclusive
• Interventions: Dietary Supplement: human milk fortified; Dietary Supplement: placebo

• Registration Number: NCT04954807
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

This is a prospective two arms parallel double-blind randomized clinical trial in LBW infants. Clinically healthy LBW infants discharge on oral feeding of human milk before 2 weeks of age (\< 15 days old) will be invited to participate in the study. Exclusively or predominantly breastfed infants will be encourage to use finger feeding as method of supplementation, but mothers can choose their own preferences if they wish to do so.

After signing the informed consent by parent, subject will be randomized to one of four group. Randomization list were prepare by one investigator who do not involve in recruitment, outcome measures and statistical analysis. Study product will be labeled as A, B, C D in similar tin. Only manufacturer know the content of these tins and the code will be revealed after statistical analysis completed. Parents will be given this 200 g tin of study product and ask to return the tin after 14 days of opening. Unblinded assistant will weight the tin before and after opening to estimate the HMF intake for 14 days.

This study will be conducted in several hospitals in Greater Jakarta.

Adherence to study protocol will be encouraged during face to face session initially in dispensing study product and subsequent visits (visit 1 at one-month-old, visit 2 at two months old). These sessions will include the reminder of the importance of following study protocol, breastfeeding support if needed and discussion about difficulties that arise. The investigators will also remind mothers via text to fill in three days diary of intake one week before each visit.

Study Timeline

• Study Start: 2020-12-08
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-07-08
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

1. Low birth weight infants (1800-2499 g) with oral feeding
2. Exclusively breastfed or predominantly breastfed (consuming term infant formula less than 50 ml/Kg BW/day) at discharge
3. Discharge from the hospital before 2 weeks of age and maximal age of enrolment is 14 days old
4. Live in greater Jakarta
5. Parents agree in writing to study participation and indicate their intention to follow study procedures.

Exclusion Criteria

Any subject who has major congenital anomaly or any other disorder(s) that infers with normal feeding, growth, and neurodevelopment.

Participating in another intervention trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Milk Fortifier	human milk fortified	human milk fortifier which contains protein, lipid, carbohydrate and micronutrients
placebo	placebo	Placebo is made of polysaccharides (0.9 g/1 g placebo) and maltose (0.1 g/1 g placebo) and minerals.

Primary Outcome Measures

Name	Time	Method
Gaining weight	three months of age	Gain in weight (g/kg initial weight \& difference) between study enrolment and three months of age

Secondary Outcome Measures

Name	Time	Method
Vomit	enrollment to three months of age	Number of subjects who reported to have vomit between groups
Average weight gain	enrollment to three months of age	Average daily weight gain (g/kg/day) from enrolment to at three months of age
Gaining length	Three months of age	Gain in length (mm initial length \& difference) from study enrolment to the age of 3 months
Head circumference	Three months of age	Gain in head circumference (mm initial head circumference \& difference) from study enrolment to the age of 3 months
Weight for age	Three months of age	Difference of weight for age (Z score) from study enrolment to the age of 3 months
Body fat percentage	Three months of age	Difference in body fat percentage between groups
Stool consistency	enrollment to three months of age	Median type of stools according to Diapered Infant stool chart between groups
Stool frequency	enrollment to three months of age	average stool frequency per day between groups
Bloating	enrollment to three months of age	Number of subjects who reported to experience bloating between groups
Fever	enrollment to three months of age	Number of subjects who reported to experience fever between groups
Rehospitalization	enrollment to three months of age	Number of subjects who reported being hospitalized between groups

Trial Locations

Locations (4)

Hermina Hospital; 🇮🇩 Bekasi, Jawa Barat, Indonesia

Budi Kemuliaan Hospital; 🇮🇩 Jakarta, Central Jakarta, Indonesia

Koja District Hospital; 🇮🇩 Jakarta, Indonesia

Pasarebo Regional Hospital; 🇮🇩 Jakarta, Indonesia