Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

Not Applicable

Completed

• Conditions: Preterm
• Interventions: Dietary Supplement: Placebo

• Registration Number: NCT05438680
• Lead Sponsor: Alexandria University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-06-13
• Study Start: 2022-06-20
• Study First Submitted QC: 2022-06-25
• Study First Posted: 2022-06-30
• Primary Completion: 2023-09-20
• Status Verified: 2023-10
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group II : control group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Fundus examination to detect retinopathy of prematurity	28 days	ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease

Secondary Outcome Measures

Name	Time	Method
-Assessment of Head circumference	28 days	measurement of Head circumference weekly.
Assessment of weight	28 days	-Assessment of weight every other day.
prematurity related complications	28 days	* late onset sepsis; * IVH; * Necrotizing enterocolitis; * bronchopulmonary dysplasia
-Assessment of length	28 days	-Assessment of length on admission and on discharge.

Trial Locations

Locations (2)

Marwa Mohamed Farag; 🇪🇬 Alexandria, Egypt

Alexandria university, Elshattbi hospital; 🇪🇬 Alexandria, Egypt