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Clinical Trials in Sweden / NCT03797157
Active, not recruiting Phase 2/3

Human Milk Fortification in Extremely Preterm Infants

NCT03797157 · tracked via the Priya Life Science Sweden tracker
Sponsor
Thomas Abrahamsson, MD, PhD
Phase
Phase 2/3
Started
2019-02-01
Last updated
2024-07-23

Condition(s) studied

Necrotizing EnterocolitisSepsisMortality

Investigational drug(s) / intervention(s)

H2MFBovine milk-based fortifier

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

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

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Gestational age at birth 22+0-27+6: based on prenatal ultrasonography. * Enteral feeds \< 100 mL/kg/day at the day of randomisation. * Written informed consent from the legal guardians of the infant. * The home clinic of the infant has the logistics of maintaining the intervention until gestational week 34+0 Exclusion Criteria: * Lethal or complicated malformation known at the time of inclusion * Chromosomal anomalies known at the time of inclusion * No realistic hope for survival at the time of inclusion * Gastrointestinal malformation known at the time of inclusion * Abdominal surgery before the time of inclusion * Participation in another intervention trial aiming at having an effect on growth, nutrition, feeding intolerance or severe complications such as NEC and sepsis * Infants having nutrient fortifier or formula prior to randomisation

Primary outcome measure(s)

  • The incidence of the composite of necrotizing enterocolitis, culture-proven sepsis and mortality — From birth until discharge from hospital (but not longer than gestational week 44+0)
    An infant should have had any of these diagnoses to fulfil the criterion

Trial sites (5)

FacilityCityRegionStatus
Queen Silvia Children´s Hospital Gothenburg Sweden
Crown Princess Victoria Children´s Hospital Linköping Sweden
Karolinska Hospital Stockholm Sweden
Norrlands Universitetssjukhus Umeå Sweden
Akademiska Barnsjukhuset Uppsala Sweden

Other trials for the same condition

Probiotic Supplementation in Extremely Preterm Infants in Scandinavia Recruiting
Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls Active, not recruiting
Bacteremia From Periodontal Treatment to Elucidate the Underpinnings of Sepsis Active, not recruiting
Establishment of Reference Limits for Blood Lactate Levels in Intensive Care Patients With a Particular Focus on Age and Sex Active, not recruiting
Inflammatory Mediators of Acute Kidney Injury in Intensive Care Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03797157 on ClinicalTrials.gov ↗ ← All trials in Sweden