Targeted Fortification of Pasteurized Donor Human Milk

NCT ID: NCT04640805

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2025-12-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group (standard fortification)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group (modified targeted fortification)

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.

Group Type: EXPERIMENTAL

Protein supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Analysis with Miris Human Milk Analyzer

Intervention Type: 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.

Interventions

Protein supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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)

• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chengsi Ong

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital, Singapore

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2020/2493

Identifier Type: -

Identifier Source: org_study_id