Human Milk Fortification in Extremely Preterm Infants

Summary

This is a randomised controlled multi-centre trial comparing the effect of diet supplementation of a human breast milk-based nutrient fortifier (H2MF®) with standard bovine protein-based nutrient fortifier in 222 extremely preterm infants (born before gestational week 28+0) exclusively fed with human breast milk (own mother´s milk and/or donor milk). The infants will be randomised to receive either the human breast-milk based H2MF® or the standard bovine protein-based nutrient fortifier when oral feeds have reached \<100 ml/kg/day.

The randomised intervention, stratified by centre, will continue until the target gestational week 34+0. The infant must not be fed with formula during the intervention period. The allocation will be concealed before inclusion, but after randomisation the study is not blinded.

Primary endpoint of the intervention is the composite variable necrotizing enterocolitis (NEC), sepsis and mortality.

The enrolled infants are characterised with clinical data including growth, feeding intolerance, use of enteral and parenteral nutrition, treatment, antibiotics and complications collected daily in a study specific case report form from birth until discharge from the hospital (not longer than gestational week 44+0). A follow up focusing on neurological development, growth and feeding problems will be performed at 2 years of age (corrected) and 5.5 years of age.

Conditions

• Necrotizing Enterocolitis
• Sepsis
• Mortality

Interventions

DIETARY_SUPPLEMENT

H2MF

H2MF is a human milk-based breastmilk fortifier for preterm infants

DIETARY_SUPPLEMENT

Bovine milk-based fortifier

Bovine milk-based fortifier is the standard breast milk fortifier in Sweden

Sponsors & Collaborators

• Sahlgrenska University Hospital

  collaborator OTHER

• Region Uppsala

  collaborator UNKNOWN

• Vasterbottens lans landsting

  collaborator UNKNOWN

• Prolacta Bioscience

  collaborator INDUSTRY

• Region Stockholm

  collaborator OTHER_GOV

• Thomas Abrahamsson, MD, PhD

  lead OTHER

Principal Investigators

• Thomas R Abrahamsson, MD, PhD · Region Östergötland

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-01

Primary Completion

2022-09-01

Completion

2029-01-31

Countries

• Sweden

Study Locations