Clinical trial NCT04954807: Indonesia After Discharge LBW Infant HMF Supplementation Study
Official title: Growth and Body Composition of Low Birth Weight Infants Supplemented With Human Milk Fortifier After Discharge: A Double-Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2021-07-08
Enrollment: 163
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gaining weight
timeFrame: three months of age
Secondary outcomes:
measure: Average weight gain
timeFrame: enrollment to three months of age
measure: Gaining length
timeFrame: Three months of age
measure: Head circumference
timeFrame: Three months of age
measure: Weight for age
timeFrame: Three months of age
measure: Body fat percentage
timeFrame: Three months of age
measure: Stool consistency
timeFrame: enrollment to three months of age
measure: Stool frequency
timeFrame: enrollment to three months of age
measure: Vomit
timeFrame: enrollment to three months of age
measure: Bloating
timeFrame: enrollment to three months of age
measure: Fever
timeFrame: enrollment to three months of age
measure: Rehospitalization
timeFrame: enrollment to three months of age
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Budi Kemuliaan Hospital
state: Central Jakarta
city: Bekasi
country: Indonesia
facility: Hermina Hospital
state: Jawa Barat
city: Jakarta
country: Indonesia
facility: Pasarebo Regional Hospital
city: Jakarta
country: Indonesia
facility: Koja District Hospital
Study officials:
affiliation: Indonesia University
name: Yoga Devaera, MD
role: PRINCIPAL_INVESTIGATOR
References: