Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates

Study Overview
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Brief Summary
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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
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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. No major adverse effects were reported in any of the studies using bovine colostrum in infants and preterm babies . In an in vitro study, the authors showed that bovine colostrum significantly reduces the adherence of various Enterobacteriaceae species known to be associated with NEC to human intestinal epithelial cells . A randomized controlled trial has shown that the use of bovine lactoferrin reduced the incidence of neonatal sepsis . Till date, there are no studies in neonates on the use of bovine colostrum for the prevention of NEC.

Official Title
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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

Conditions
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NEC

Intervention / Treatment
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* Dietary Supplement: bovine colostrum


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remuverol<br>The neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier. | Dietary Supplement: bovine colostrum<br>* The neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be definite NEC | Subjects who will be suspected to have NEC (based on clinical features) undergo an abdominal X-ray and stool occult blood assay. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Numerical variables will be compared by Student's t-test or Mann Whitney U-test, depending on distribution. | baseline |