Completed

Human vs. Bovine Milk-based Fortifiers for Very Preterm Infants: A Comparative Analysis

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Study Aim

This observational study compares the effects of human and bovine milk-based fortifiers in very preterm infants, focusing on the occurrence of a composite of necrotizing enterocolitis (NEC), culture-proven late-onset sepsis, mortality, and the percentage of infants with an interruption in enteral feeding.

What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Neonatal Sepsis+14

+ Death

+ Digestive System Diseases

1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: October 2014
See protocol details

Summary

Principal SponsorThe Hospital for Sick Children
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2014

Actual date on which the first participant was enrolled.

This study focuses on very preterm infants who weigh less than expected at birth. While mother's milk is the best food for these infants, it often doesn't provide all the nutrients they need. To fill this gap, doctors usually add nutrient fortifiers made from cow's milk. However, there's growing interest in using fortifiers made from human milk instead, as they might be safer and healthier. This study aims to compare the effects of using human milk-based fortifiers (HMBF) and cow's milk-based fortifiers (BMBF) on the health of these preterm infants. It looks at data from two previous studies where infants were fed either with HMBF or BMBF. The study's goal is to understand if using HMBF can lower the risk of death, severe illness, or major feeding interruptions during the infants' hospital stay. In this study, participants from the two previous trials were either fed with HMBF or BMBF. The feeding intervention started as soon as the infants were assigned to one of these two groups. One of the studies allowed for personalized fortification based on milk analysis, while the other used standard fortification. The feeding intervention continued until the infants reached a certain age, were discharged, or started eating solid food. The study measured two main outcomes. First, it checked if the infants developed a serious digestive problem called NEC, a severe infection known as late-onset sepsis, or if they passed away. Second, it recorded if there were any interruptions in the infants' feeding that lasted for 12 hours or more, or if the feeding volume was reduced by more than half over the same time period.

Official TitleNutrient Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: an Individual Participant Data Meta-analysis
Principal SponsorThe Hospital for Sick Children
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

355 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neonatal SepsisDeathDigestive System DiseasesEnterocolitisGastroenteritisGastrointestinal DiseasesInfant, Newborn, DiseasesInfectionsInflammationIntestinal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeSepsisEnterocolitis, NecrotizingInfant Death

Criteria

1 inclusion criteria required to participate
Infant is a participant of the OptiMoM or the N-Forte trial

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

The Hospital for Sick Children

Toronto, CanadaOpen The Hospital for Sick Children in Google Maps
Suspended

Umeå University

Umeå, Sweden
Completed2 Study Centers