Breast Feeding, Exclusive Clinical Trial
— DAHLIAOfficial title:
Growth and Body Composition of Low Birth Weight Infants Supplemented With Human Milk Fortifier After Discharge: A Double-Blind Randomized Clinical Trial
Verified date | March 2022 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 163 |
Est. completion date | February 25, 2022 |
Est. primary completion date | February 23, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 14 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Hermina Hospital | Bekasi | Jawa Barat |
Indonesia | Budi Kemuliaan Hospital | Jakarta | Central Jakarta |
Indonesia | Koja District Hospital | Jakarta | |
Indonesia | Pasarebo Regional Hospital | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University | Ludwig-Maximilians - University of Munich |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gaining weight | Gain in weight (g/kg initial weight & difference) between study enrolment and three months of age | three months of age | |
Secondary | Average weight gain | Average daily weight gain (g/kg/day) from enrolment to at three months of age | enrollment to three months of age | |
Secondary | Gaining length | Gain in length (mm initial length & difference) from study enrolment to the age of 3 months | Three months of age | |
Secondary | Head circumference | Gain in head circumference (mm initial head circumference & difference) from study enrolment to the age of 3 months | Three months of age | |
Secondary | Weight for age | Difference of weight for age (Z score) from study enrolment to the age of 3 months | Three months of age | |
Secondary | Body fat percentage | Difference in body fat percentage between groups | Three months of age | |
Secondary | Stool consistency | Median type of stools according to Diapered Infant stool chart between groups | enrollment to three months of age | |
Secondary | Stool frequency | average stool frequency per day between groups | enrollment to three months of age | |
Secondary | Vomit | Number of subjects who reported to have vomit between groups | enrollment to three months of age | |
Secondary | Bloating | Number of subjects who reported to experience bloating between groups | enrollment to three months of age | |
Secondary | Fever | Number of subjects who reported to experience fever between groups | enrollment to three months of age | |
Secondary | Rehospitalization | Number of subjects who reported being hospitalized between groups | enrollment to three months of age |
Status | Clinical Trial | Phase | |
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