Status:
UNKNOWN
Targeted vs Standard Fortification of Breast Milk
Lead Sponsor:
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Collaborating Sponsors:
Medical University of Warsaw
Institute of Mother and Child
Conditions:
BPD - Bronchopulmonary Dysplasia
NEC - Necrotizing Enterocolitis
Eligibility:
All Genders
Up to 32 years
Phase:
NA
Brief Summary
BACKGROUND: Human milk (HM) is recommended for all very low birth infants (VLBW)). Breast-milk is highly variable in nutrient content, failing to meet the nutritional demands of VLBW. Fortification o...
Detailed Description
Study design and setting This is a multi-centre superiority randomised parallel group, 1:1 allocation study. Patients will be recruited at three departments of neonatology and intensive care units: De...
Eligibility Criteria
Inclusion
- Patients eligible for the trial must comply with all of the following at randomization:
- Gestational age at birth ≤ 32 weeks
- Enteral feeding of at least 80ml/kg/day
- Donor or maternal milk based enteral feeding (at least 50%)
- Parenteral/legal guardian consent
Exclusion
- \>50% formula based enteral feeding
- Small for gestational age (birth weight \< 3rd percentile)
- Congenital abnormalities which increase the risk of NEC
- NEC
- Withdrawal of feeding \> 7 days
- Sepsis
- Death
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03775785
Start Date
July 1 2019
End Date
December 31 2024
Last Update
January 14 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, Poland, 00-315
2
Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw
Warsaw, Poland, 02-015