Human Milk-derived Fortification in Preterm Infants

NCT ID: NCT05228847

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2025-05-30

Brief Summary

Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Multi-nutrient human milk fortifiers (HMFs) are designed to meet the macro and micro-nutrient needs of VLBW infants. HMFs differ by the origin of milk and by nutrient composition. Traditionally, bovine milk has been the main source of multi-nutrient HMFs.

Detailed Description

Recent advances in lacto-engineering techniques allowed the manufacturing of multi-nutrient HMF from human milk as an alternative to bovine milk. Since exposure to infant bovine-based formula feeds is frequently shown to increase neonatal morbidities, human milk-derived HMFs (H-HMFs) have been frequently proposed to minimize exposure to bovine products prior to 34 weeks gestation with an intent to decrease the risks of necrotizing enterocolitis and feeding intolerance. The use of multi-nutrient H-HMFs is a promising intervention however currently available H-HMFs are expensive.

The main objective of this randomized controlled trial is to compare the weight gain achieved by preterm infants born <1250 g and fed human milk fortified with H-HMFs (made from mother's own milk (MOM) when MOM supply exceeds the daily need of her preterm infant or from donor human milk (DHM) compared with counterparts fed human milk fortified with the currently used bovine-derived fortifier (B-HMF).

Conditions

Postnatal Growth Restriction; Necrotizing Enterocolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Human milk-derived HMF

Fortification with human milk-derived product

Group Type: ACTIVE_COMPARATOR

Human milk-derived HMF

Intervention Type: DIETARY_SUPPLEMENT

Fortification with human milk-derived product

Bovine milk-derived HMF

Current standard practice: Fortification with bovine milk-derived product

Group Type: OTHER

bovine milk-derived HMF

Intervention Type: DIETARY_SUPPLEMENT

bovine milk-derived HMF

Interventions

Human milk-derived HMF

Fortification with human milk-derived product

Intervention Type: DIETARY_SUPPLEMENT

bovine milk-derived HMF

bovine milk-derived HMF

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Birthweight between 400 g-1250 g
• Less than or 32 weeks gestational age at birth
• Subject has been classified as appropriate for gestational age
• Enteral feeding of human milk is initiated by 72 hours
• Subject is expected to be on human milk for at least 3 weeks.

Exclusion Criteria

• Congenital abnormalities or underlying disease that may affect growth
• Maternal cocaine, alcohol, or opioid abuse during pregnancy
• Mother or infant is currently receiving treatment for HIV infection
• Infant with major surgery

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Belal Alshaikh

Clinical Associate Professor, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Belal Alshaikh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Countries

Canada

Central Contacts

Belal Alshaikh, MD, MSc

Role: CONTACT

balshaik@ucalgary.ca

4039561588

Other Identifiers

REB22-039

Identifier Type: -

Identifier Source: org_study_id