NCT05438680

Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 1 Hour – 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-20
• Primary completion: 2023-09-20
• Completion: 2023-10-01
• First posted: 2022-06-30
• Last updated: 2023-10-12

Locations

2 sites across 1 country: Egypt