Status:
COMPLETED
Bovine Colostrum as a Human Milk Fortifier for Preterm Infants
Lead Sponsor:
Per Torp Sangild
Conditions:
Feeding Intolerance
Necrotizing Enterocolitis
Eligibility:
All Genders
5-3 years
Phase:
NA
Brief Summary
Very preterm infants (\<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development. In the first weeks, they have difficulties tolerating enteral ...
Detailed Description
Objectives 1. To test if fortification of human milk with BC reduces feeding intolerance compared with currently used HMF. 2. To verify the safety and tolerability of BC fortification and to monitor ...
Eligibility Criteria
Inclusion
- Very preterm infants born between gestational age 26 + 0 and 30 + 6 weeks (from the first day of the mother's last menstrual period and/or based on fetal ultrasound)
- DM is given at the unit when MM is absent (or insufficient in amount)
- Infants judged by the attending physician to be in need of nutrient fortification, as added in the form of HMF to MM and/or DM
- Signed parental consent
Exclusion
- Major congenital anomalies and birth defects
- Infants who have had gastrointestinal surgery prior to randomization
- Infants who have received IF prior to randomization
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2021
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT03822104
Start Date
May 1 2019
End Date
July 8 2021
Last Update
January 28 2022
Active Locations (2)
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1
Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)
Shenzhen, Guangdong, China, 518133
2
Shenzhen Nanshan People's Hospital
Shenzhen, China