Targeted Fortification of Pasteurized Donor Human Milk

Growth Failure Clinical Trial

Official title:

Targeted Fortification of Pasteurized Donor Human Milk to Improve Growth in Very Low Birth Weight Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04640805
• Other study ID #: 2020/2493
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 2, 2024

Study information

• Verified date: September 2020
• Source: KK Women's and Children's Hospital
• Contact: Chengsi Ong
• Phone: 6394 1646
• Email: ong.chengsi[@]kkh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Birth Weight
• Donor Breast Milk
• Failure to Thrive
• Growth Failure
• Very Low Birth Weight Infant

Intervention

Dietary Supplement:
• Protein supplementation
Liquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume.

Other:
• Analysis 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.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

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