Clinical trial NCT04640805: Targeted Fortification of Pasteurized Donor Human Milk
Official title: Targeted Fortification of Pasteurized Donor Human Milk to Improve Growth in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Very Low Birth Weight Infant
Growth Failure
Donor Breast Milk
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2020-11-23
Enrollment: 61
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment to study group will be done in a 1:1 ratio. Twins/triplets will be randomized to the same group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Malnutrition rate
timeFrame: Hospital discharge or 37 weeks gestation, whichever earlier
Secondary outcomes:
measure: Linear growth
timeFrame: Hospital discharge or 37 weeks post menstrual age, whichever earlier
measure: Body composition
timeFrame: Hospital discharge or 37 weeks gestation, whichever earlier
measure: Head circumference growth
timeFrame: Hospital discharge or 37 weeks gestation, whichever earlier
measure: High calorie formula use
timeFrame: Hospital discharge or 35 weeks gestation, whichever earlier
measure: Bronchopulmonary dysplasia
timeFrame: Hospital discharge or 37 weeks gestation, whichever earlier
measure: Retinopathy of prematurity
timeFrame: Hospital discharge or 37 weeks gestation, whichever earlier
Other outcomes:
measure: Neurodevelopmental scores
timeFrame: 18 to 24 months post menstrual age
measure: Infant motor performance
timeFrame: Hospital discharge or 37 weeks gestation, whichever earlier
measure: Duration of hospital stay
timeFrame: Hospital discharge, assessed up to 180 days post menstrual age
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital, Singapore
name: Chengsi Ong
role: PRINCIPAL_INVESTIGATOR
References: