Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates: a Prospective Study at Neonatology Unit of Children's Hospital Assiut University
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 65
- Primary Endpoint
- The primary outcome will be definite NEC
Study Overview
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 Aim: To improve outcomes of neonatal sepsis and NEC in the pe-terrms and to decrease their hospital stay.
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 researchers believe that an exaggerated inflammatory response mounted by immature intestinal epithelial cells in response to abnormal intestinal colonization plays a vital role in the pathogenesis of NEC and bacteria belonging to Enterobacteriaceae have often been linked to NEC .
Colonization with commensal bacteria soon after birth is essential for the development of normal intestinal function however, this process is often altered in premature babies in NICUs, leading to colonization with pathogenic bacteria .
Commercially available bovine colostrum has high concentrations of anti-infective factors such as immunoglobulins, lactoferrin, organism-specific antibodies, lactoperoxidase, insulin-like growth factors and transforming growth factors.
These components have substantial homology to their human counterparts . Bovine colostrums has been tried in the treatment of Escherichia coli and Shigella and Rotavirus diarrhea in children, Helicobacter pylori infection in children and E. coli intestinal infection in term and preterm neonates.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 5 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Babies with birth weight ≤ 1500 g
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
The primary outcome will be definite NEC
Time Frame: baseline
Subjects who will be suspected to have NEC (based on clinical features) undergo an abdominal X-ray and stool occult blood assay.
Secondary Outcomes
- Descriptive statistics will be used for describing baseline variables.Dichotomous outcomes will be compared by Chi square test with continuity correction or Fisher's Exact as applicable.(baseline)
Investigators
Mohamed Kamal Ali Abd El Hameed
principle investigator
Assiut University