Status:
ACTIVE_NOT_RECRUITING
Human Milk Fortification in Extremely Preterm Infants
Lead Sponsor:
Thomas Abrahamsson, MD, PhD
Collaborating Sponsors:
Sahlgrenska University Hospital
Region Uppsala
Conditions:
Necrotizing Enterocolitis
Sepsis
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief 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 fort...
Detailed Description
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 fort...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2029
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT03797157
Start Date
February 1 2019
End Date
January 31 2029
Last Update
July 23 2024
Active Locations (5)
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1
Queen Silvia Children´s Hospital
Gothenburg, Sweden
2
Crown Princess Victoria Children´s Hospital
Linköping, Sweden
3
Karolinska Hospital
Stockholm, Sweden
4
Norrlands Universitetssjukhus
Umeå, Sweden