Status:
UNKNOWN
Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates
Lead Sponsor:
Assiut University
Conditions:
NEC
Eligibility:
All Genders
1-5 years
Brief Summary
Primary Aim: The aim of this study is to investigate the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants. Secondary Ai...
Detailed Description
Necrotizing enterocolitis (NEC) primarily occurs in premature and very low birth weight (VLBW) babies, the incidence varying from 5 to 10% in various neonatal intensive care unit (NICUs) . Many resea...
Eligibility Criteria
Inclusion
- Babies with birth weight ≤ 1500 g
Exclusion
- Babies who have any contraindication for initiating milk feeds; who will fail to achieve adequate feed volume to be able to administer the study drug.
- Those with suspected/ proven gastrointestinal malformations.
- Preexisting sepsis (definite or suspect) or NEC at the time of enrollment.
- Those with a family history of an inborn error metabolism (that precludes exposure to proteins/lactose).
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04886674
Start Date
July 1 2021
End Date
July 1 2022
Last Update
May 14 2021
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