Indonesia After Discharge LBW Infant HMF Supplementation Study (DAHLIA)

Growth and Body Composition of Low Birth Weight Infants Supplemented With Human Milk Fortifier After Discharge: A Double-Blind Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Gestational Age and Weight Conditions; Breast Feeding, Exclusive; Low; Birthweight
• Intervention / Treatment: Dietary supplement: human milk fortified; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 13760
    • Pasarebo Regional Hospital
  • Jakarta, Indonesia
    • Koja District Hospital
  • Central Jakarta
    • Jakarta, Central Jakarta, Indonesia, 10110
      • Budi Kemuliaan Hospital
  • Jawa Barat
    • Bekasi, Jawa Barat, Indonesia
      • Hermina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Human Milk Fortifier; human milk fortifier which contains protein, lipid, carbohydrate and micronutrients	Dietary supplement: human milk fortified; HMF will be given 6 scoops a day
PLACEBO_COMPARATOR: placebo; Placebo is made of polysaccharides (0.9 g/1 g placebo) and maltose (0.1 g/1 g placebo) and minerals.	Dietary supplement: placebo; Placebo will be given six scoops a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gaining weight	Gain in weight (g/kg initial weight & difference) between study enrolment and three months of age	three months of age

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Yoga Devaera, MD, Indonesia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2020
• Primary Completion (ACTUAL): February 23, 2022
• Study Completion (ACTUAL): February 25, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (ACTUAL): July 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Breast Feeding; Body Mass Index; Human Milk Fortifier; Low Birth Weight; Small Gestational Age
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 20-02-0127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol will be published in a scientific journal. Others data will be available upon request to principle investigator.
• IPD Sharing Time Frame: Upon acceptance in scientific journal in one year from data completion
• IPD Sharing Access Criteria: Open access according to the journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No