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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
HMF will be given 6 scoops a day
Placebo will be given six scoops a day
Budi Kemuliaan Hospital
Jakarta, Central Jakarta, Indonesia
Hermina Hospital
Bekasi, West Java, Indonesia
Pasarebo Regional Hospital
Jakarta, Indonesia
Koja District Hospital
Jakarta, Indonesia
Gaining weight
Gain in weight (g/kg initial weight \& difference) between study enrolment and three months of age
Time frame: three months of age
Average weight gain
Average daily weight gain (g/kg/day) from enrolment to at three months of age
Time frame: enrollment to three months of age
Gaining length
Gain in length (mm initial length \& difference) from study enrolment to the age of 3 months
Time frame: Three months of age
Head circumference
Gain in head circumference (mm initial head circumference \& difference) from study enrolment to the age of 3 months
Time frame: Three months of age
Weight for age
Difference of weight for age (Z score) from study enrolment to the age of 3 months
Time frame: Three months of age
Body fat percentage
Difference in body fat percentage between groups
Time frame: Three months of age
Stool consistency
Median type of stools according to Diapered Infant stool chart between groups
Time frame: enrollment to three months of age
Stool frequency
average stool frequency per day between groups
Time frame: enrollment to three months of age
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QUADRUPLE
Enrollment
163
Vomit
Number of subjects who reported to have vomit between groups
Time frame: enrollment to three months of age
Bloating
Number of subjects who reported to experience bloating between groups
Time frame: enrollment to three months of age
Fever
Number of subjects who reported to experience fever between groups
Time frame: enrollment to three months of age
Rehospitalization
Number of subjects who reported being hospitalized between groups
Time frame: enrollment to three months of age