An interventional study of Protein supplementation and Analysis with Miris Human Milk Analyzer in Very Low Birth Weight Infant, Growth Failure and Donor Breast Milk, sponsored by KK Women's and Children's Hospital. Active, not recruiting at 1 site in Singapore. Open to participants aged Up to 37 Weeks. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's enrollment of 61 is below the median of 100 across 56 interventional studies indexed under Failure to Thrive.
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Exclusion Criteria:
Pasteurized Donor Human Milk (PDHM) will be fortified as per unit protocols, at 1 packet of Human Milk Fortifier (Similac or Pre-Nan) to every 25ml PDHM at a feed volume of 80ml/kg/day
Pasteurized Donor Human Milk (PDHM) will be analyzed using the Miris Human Milk Analyzer, and PDHM with a fat content of 3.8g/dL or higher will be selected. Additional protein will be added using liquid protein fortifier (Similac) at 1ml to every 25ml PDHM to give an additional 0.67g/dL protein.
Dietary Supplement: Protein supplementation · Other: Analysis with Miris Human Milk Analyzer
Liquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume.
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.
Malnutrition rate
Malnutrition is defined as a decline in weight z-score from birth of 0.8 or more
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Linear growth
Linear growth will be assessed using z-score changes from birth
Time frame: Hospital discharge or 37 weeks post menstrual age, whichever earlier
Body composition
Percent fat mass and fat-free mass measured using air displacement plethysmography
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Head circumference growth
Head circumference will be assessed using z-score changes from birth
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
High calorie formula use
Proportion of high calorie formula use (e.g. 27kcal/oz or 30kcal/oz formula)
Time frame: Hospital discharge or 35 weeks gestation, whichever earlier
Bronchopulmonary dysplasia
Proportion of patients with bronchopulmonary dysplasia
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Retinopathy of prematurity
Proportion of patients with retinopathy of prematurity
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Neurodevelopmental scores
Bayley Scales of Infant and Toddler Development scale scores
Time frame: 18 to 24 months post menstrual age
Infant motor performance
Test of Infant Motor Performance scores measured by trained physiotherapists
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Duration of hospital stay
Days of hospital stay, up to 180 days post menstrual age
Time frame: Hospital discharge, assessed up to 180 days post menstrual age
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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