Donor Breast Milk, Growth Failure, Very Low Birth Weight Infant
Conditions
Brief summary
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.
Detailed description
Our hospital milk bank provides pasteurized donor human milk (PDHM) to very low birth weight (VLBW) infants without sufficient mother's milk, with the overall aim of lowering the risk of necrotizing enterocolitis in this population. However, with the introduction of PDHM in our setting, rates of suboptimal weight gain have increased (60.2% to 65.7%). This is likely due to the fact that PDHM is often lower in energy and protein than preterm mother's own milk. One solution to delivery adequate nutrition in this VLBWs receiving PDHM, is targeted fortification, which involves measurement of the macronutrient content of human milk, and adding extra macronutrients to reach nutrient goals. In this proposed study, we will conduct a pilot randomized controlled trial of a modified targeted fortification versus standard care. This study will include preterm VLBW infants (\<1500g), without congenital conditions resulting in growth restriction, and receiving \>25% of PDHM use in the first week of life. 40 patients in each arm will be recruited over a period of 2 years. The intervention group will receive a modified targeted fortification, consisting of selection of high fat PDHM (3.8g/dL or more) with the addition of protein fortification of 0.67g/dL from week 2 of life until a gestational age of 37 weeks or hospital discharge, whichever earlier. The control group will receive usual regular PDHM with standard fortification using human milk fortifier as per current practice. The primary outcome is the rate of suboptimal growth (drop in weight z-score from birth ≥0.8) at discharge or 37 weeks. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.
Interventions
DIETARY_SUPPLEMENTProtein supplementation
Liquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume.
OTHERAnalysis with Miris Human Milk Analyzer
PDHM macronutrient content will be analyzed using the Miris Human Milk Analyzer and PDHM with fat content of 3.8g/dL or higher will be selected and provided.
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Assignment to study group will be done in a 1:1 ratio. Twins/triplets will be randomized to the same group.
Eligibility
Sex/Gender
ALL
Age
No minimum to 37 Weeks
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malnutrition rate | Hospital discharge or 37 weeks gestation, whichever earlier | Malnutrition is defined as a decline in weight z-score from birth of 0.8 or more |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head circumference growth | Hospital discharge or 37 weeks gestation, whichever earlier | Head circumference will be assessed using z-score changes from birth |
| High calorie formula use | Hospital discharge or 35 weeks gestation, whichever earlier | Proportion of high calorie formula use (e.g. 27kcal/oz or 30kcal/oz formula) |
| Bronchopulmonary dysplasia | Hospital discharge or 37 weeks gestation, whichever earlier | Proportion of patients with bronchopulmonary dysplasia |
| Retinopathy of prematurity | Hospital discharge or 37 weeks gestation, whichever earlier | Proportion of patients with retinopathy of prematurity |
| Linear growth | Hospital discharge or 37 weeks post menstrual age, whichever earlier | Linear growth will be assessed using z-score changes from birth |
| Body composition | Hospital discharge or 37 weeks gestation, whichever earlier | Percent fat mass and fat-free mass measured using air displacement plethysmography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | Hospital discharge, assessed up to 180 days post menstrual age | Days of hospital stay, up to 180 days post menstrual age |
| Neurodevelopmental scores | 18 to 24 months post menstrual age | Bayley Scales of Infant and Toddler Development scale scores |
| Infant motor performance | Hospital discharge or 37 weeks gestation, whichever earlier | Test of Infant Motor Performance scores measured by trained physiotherapists |
Countries
Singapore
Outcome results
None listed