Indonesia After Discharge LBW Infant HMF Supplementation Study

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: human milk fortified
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Human Milk Fortifier<br>human milk fortifier which contains protein, lipid, carbohydrate and micronutrients | Dietary Supplement: human milk fortified<br>* HMF will be given 6 scoops a day<br>|
| Placebo Comparator: placebo<br>Placebo is made of polysaccharides (0.9 g/1 g placebo) and maltose (0.1 g/1 g placebo) and minerals. | Dietary Supplement: placebo<br>* Placebo will be given six scoops a day<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Birth Weight, Breast Feeding, Body Mass Index, Human Milk Fortifier, Small Gestational Age