Indonesia After Discharge LBW Infant HMF Supplementation Study
Condition: Low; Birthweight; Breast Feeding, Exclusive; Gestational Age and Weight Conditions
MeSH terms: Birth Weight
Study type: Interventional

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.
    

Intervention name(s): human milk fortified; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): HMF will be given 6 scoops a day; Placebo will be given six scoops a day
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Low Birth Weight; Breast Feeding; Body Mass Index; Human Milk Fortifier; Small Gestational Age