Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2023-10-01

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.

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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:

1. First phase: Enrollment and selection phase.
2. Second phase: Intervention phase ( enteral bovine colostrum administration) .
3. Third phase: Evaluation phase.
4. Fourth phase: collected data analysis and results.

Conditions

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Preterm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I: bovine colostrum group

Group Type ACTIVE_COMPARATOR

The bovine colostrum ( trade name : baby steps sachets, 300mg )

Intervention Type DIETARY_SUPPLEMENT

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.

group II : control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

distilled water with no bovine colostrum

Interventions

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The bovine colostrum ( trade name : baby steps sachets, 300mg )

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

distilled water with no bovine colostrum

Intervention Type DIETARY_SUPPLEMENT

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

Patients with any of the following will be excluded:

1. Obvious major congenital abnormalities.
2. Infants expected to be \>72 hours of age at the time of randomization.
3. Parental consent lacking/refusal

Minimum Eligible Age

1 Hour

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No