Indonesia After Discharge LBW Infant HMF Supplementation Study

NCT04954807 | Completed DMC

• 1 other identifier: 20-02-0127
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Low Birth Weight; Breast Feeding; Body Mass Index; Human Milk Fortifier; Small Gestational Age

Outcome Measures

Primary Outcomes (1)

• Gaining weight

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

  three months of age

Secondary Outcomes (11)

• Average weight gain

  enrollment to three months of age

• Gaining length

  Three months of age

• Head circumference

  Three months of age

• Weight for age

  Three months of age

• Body fat percentage

  Three months of age

Study Arms (2)

Human Milk Fortifier

ACTIVE COMPARATOR

human milk fortifier which contains protein, lipid, carbohydrate and micronutrients

Dietary Supplement: human milk fortified

placebo

PLACEBO COMPARATOR

Placebo is made of polysaccharides (0.9 g/1 g placebo) and maltose (0.1 g/1 g placebo) and minerals.

Dietary Supplement: placebo

Interventions

human milk fortified DIETARY_SUPPLEMENT

HMF will be given 6 scoops a day

Human Milk Fortifier

placebo DIETARY_SUPPLEMENT

Placebo will be given six scoops a day

placebo

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (4)

Budi Kemuliaan Hospital

Jakarta, Central Jakarta, 10110, Indonesia

Location

Hermina Hospital

Bekasi, West Java, Indonesia

Location

Pasarebo Regional Hospital

Jakarta, 13760, Indonesia

Location

Koja District Hospital

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Birth Weight; Breast Feeding

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Yoga Devaera, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One investigator who do not involve in recruitment and outcome measures will generate randomization list by computer application and set up the list into Redcap randomization set up. No one except him will know the sequence of randomization. Research assistant will randomize subjects into one of four group according to Redcap assignment. The manufacturer prepare the study product into four groups: A,B,C,D and kept the code until the statistical analysis completed. All investigators, care providers and study subjects aware of the active or placebo group. Research assistants who recruit the study subject are not allowed to open the tin. One research assistant who does no meet study subject will measure the weight of tin before and after the supplementation. Subject only meet with researchers individually and will not meet other subjects so they will not know the content of the other tin.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division of Nutrition and Metabolic Diseases of Child Health Dept

Model Details: Subjects in the intervention group will be given the new human milk fortifier which contains protein, lipid, carbohydrate and micronutrients while the control group will receive placebo (polysaccharides 0.9 g/1 g placebo and maltose 0.1 g/1 g placebo and minerals). Assuming the average weight is 2 Kg, 6 scoops (@1.0 g) will provide 1.95 g protein and 25.5 Kcal in the intervention group while 6 scoops of 1.1 g in the control group will provide 26.4 Kcal with no protein. Three times a day, supplementation with 2.0 gram (intervention group) or 2.2 gram (control group) of study product will be provided, regardless of the actual weight of the subject. Both groups will receive iron supplementation 2 drops daily (5 mg elemental iron in forms of Fe III hydroxide polymaltose complex) since 2 month old as a routine supplementation recommended by Indonesian Pediatrics Society.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 8, 2021
• Study Start: December 8, 2020
• Primary Completion: February 23, 2022
• Study Completion: February 25, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon acceptance in scientific journal in one year from data completion
• Access Criteria: Open access according to the journal

Locations

ID (4)