Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

Study Overview
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Brief Summary
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The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay.

Detailed Description
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This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital. The study will be carried out in 4 phases: First phase: Enrollment and selection phase. Second phase: Intervention phase ( enteral bovine colostrum administration) . Third phase: Evaluation phase. Fourth phase: collected data analysis and results.

Official Title
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Evaluation of the Effect of Bovine Colostrum in Prevention of Late Onset Sepsis and Retinopathy of Prematurity

Conditions
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Preterm

Intervention / Treatment
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* Dietary Supplement: The bovine colostrum ( trade name : baby steps sachets, 300mg )
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life Exclusion Criteria: Exclusion criteria Patients with any of the following will be excluded: Obvious major congenital abnormalities. Infants expected to be >72 hours of age at the time of randomization. Parental consent lacking/refusal

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 3 Days

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I: bovine colostrum group<br> | Dietary Supplement: The bovine colostrum ( trade name : baby steps sachets, 300mg )<br>* The bovine colostrum sachets will be used in a dose of 3.5ml/kg/ day , starting from the first 3 days after birth, for 14 days. Enteral route, either through nasogastric tube or orally.<br>|
| Placebo Comparator: group II : control group<br> | Dietary Supplement: Placebo<br>* distilled water with no bovine colostrum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fundus examination to detect retinopathy of prematurity | ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prematurity related complications | late onset sepsis IVH Necrotizing enterocolitis bronchopulmonary dysplasia | 28 days | 
| Assessment of weight | -Assessment of weight every other day. | 28 days | 
| -Assessment of Head circumference | measurement of Head circumference weekly. | 28 days | 
| -Assessment of length | -Assessment of length on admission and on discharge. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature infants, colostrum, ROP