Trials / Completed
CompletedNCT04954807
Indonesia After Discharge LBW Infant HMF Supplementation Study
Growth and Body Composition of Low Birth Weight Infants Supplemented With Human Milk Fortifier After Discharge: A Double-Blind Randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 163 (actual)
- Sponsor
- Indonesia University · Academic / Other
- Sex
- All
- Age
- 1 Day – 14 Days
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | human milk fortified | HMF will be given 6 scoops a day |
| DIETARY_SUPPLEMENT | placebo | Placebo will be given six scoops a day |
Timeline
- Start date
- 2020-12-08
- Primary completion
- 2022-02-23
- Completion
- 2022-02-25
- First posted
- 2021-07-08
- Last updated
- 2022-03-07
Locations
4 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04954807. Inclusion in this directory is not an endorsement.