Targeted Fortification of Pasteurized Donor Human Milk

NCT04640805 | Active Not Recruiting

• 1 other identifier: 2020/2493
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Low Birth Weight Infant; Growth Failure; Donor Breast Milk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Linear growth

  Hospital discharge or 37 weeks post menstrual age, whichever earlier

• Body composition

  Hospital discharge or 37 weeks gestation, whichever earlier

• Head circumference growth

  Hospital discharge or 37 weeks gestation, whichever earlier

• High calorie formula use

  Hospital discharge or 35 weeks gestation, whichever earlier

• Bronchopulmonary dysplasia

  Hospital discharge or 37 weeks gestation, whichever earlier

Other Outcomes (3)

• Neurodevelopmental scores

  18 to 24 months post menstrual age

• Infant motor performance

  Hospital discharge or 37 weeks gestation, whichever earlier

• Duration of hospital stay

  Hospital discharge, assessed up to 180 days post menstrual age

Study Arms (2)

Control group (standard fortification)

NO INTERVENTION

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

Intervention group (modified targeted fortification)

EXPERIMENTAL

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

Interventions

Protein supplementation DIETARY_SUPPLEMENT

Liquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume.

Intervention group (modified targeted fortification)

Analysis with Miris Human Milk Analyzer OTHER

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.

Intervention group (modified targeted fortification)

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chengsi Ong

  KK Women's and Children's Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Assignment to study group will be done in a 1:1 ratio. Twins/triplets will be randomized to the same group.

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 23, 2020
• Study Start: March 1, 2021
• Primary Completion: September 21, 2023
• Study Completion: December 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

SG (1)