Growth Failure Clinical Trial
Official title:
Targeted Fortification of Pasteurized Donor Human Milk to Improve Growth in Very Low Birth Weight Infants
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs). Pools of PDHM will be analyzed for macronutrient content using the Miris Human Milk Analyzer. The control arm will receive standard of care, which is PDHM without additional protein fortification. The intervention arm will receive PDHM with a fat content of 3.8g/dL or more, with additional protein fortification of 0.67g/dL. Primary outcome will be rate of malnutrition at hospital discharge or 37 weeks, whichever earlier. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | January 2, 2024 |
Est. primary completion date | January 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 37 Weeks |
Eligibility | Inclusion Criteria: - Birth weight less than or equal to 1500g - Born at our study hospital or transferred to study hospital within first week of life - Achieving at least 40ml/kg/day of enteral feeds by day 7 of life - Receiving at least 25% of pasteurized donor human milk within first 7 days of life Exclusion Criteria: - Diagnosed or suspected inborn errors of metabolism - Acute or chronic renal impairment - Congenital disease associated with significant growth impairment (including, but not limited to, Trisomy 21, neonatal encephalopathy and seizures, neonatal tumours, achondroplasia, complex congenital heart disease, anorectal malformations, gastrointestinal disorders) |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Neurodevelopmental scores | Bayley Scales of Infant and Toddler Development scale scores | 18 to 24 months post menstrual age | |
Other | Infant motor performance | Test of Infant Motor Performance scores measured by trained physiotherapists | Hospital discharge or 37 weeks gestation, whichever earlier | |
Other | Duration of hospital stay | Days of hospital stay | Hospital discharge, assessed up to 180 days post menstrual age | |
Primary | Malnutrition rate | Malnutrition is defined as a decline in weight z-score from birth of 0.8 or more | Hospital discharge or 37 weeks gestation, whichever earlier | |
Secondary | Linear growth | Linear growth will be assessed using z-score changes from birth | Hospital discharge or 37 weeks post menstrual age, whichever earlier | |
Secondary | Body composition | Percent fat mass and fat-free mass measured using air displacement plethysmography | Hospital discharge or 37 weeks gestation, whichever earlier | |
Secondary | Head circumference growth | Head circumference will be assessed using z-score changes from birth | Hospital discharge or 37 weeks gestation, whichever earlier | |
Secondary | High calorie formula use | Proportion of high calorie formula use (e.g. 27kcal/oz or 30kcal/oz formula) | Hospital discharge or 35 weeks gestation, whichever earlier | |
Secondary | Bronchopulmonary dysplasia | Proportion of patients with bronchopulmonary dysplasia | Hospital discharge or 37 weeks gestation, whichever earlier | |
Secondary | Retinopathy of prematurity | Proportion of patients with retinopathy of prematurity | Hospital discharge or 37 weeks gestation, whichever earlier |
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