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Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

NCT05438680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-10-12

No results posted yet for this study

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.

Conditions

  • Preterm

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo

distilled water with no bovine colostrum

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Mohamed Alaaaldin Thabet, PhD · Faculty of medicine, Alexandria University, Egypt

  • Islam Shereen Hamdy, PhD · Faculty of medicine, Alexandria University, Egypt

  • Eman Shabban Mohamed, MBBCh · Faculty of medicine, Alexandria University, Egypt

  • Marwa Mohamed Farag, PhD · Faculty of medicine, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-20
Primary Completion
2023-09-20
Completion
2023-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438680 on ClinicalTrials.gov