Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

Preterm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438680
• Other study ID #: 0106797
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 1, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Preterm
• Retinopathy of Prematurity

Intervention

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.
• Placebo
distilled water with no bovine colostrum

Locations

Country	Name	City	State
Egypt	Alexandria university, Elshattbi hospital	Alexandria
Egypt	Marwa Mohamed Farag	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	prematurity related complications	late onset sepsis; IVH; Necrotizing enterocolitis; bronchopulmonary dysplasia	28 days
Secondary	Assessment of weight	-Assessment of weight every other day.	28 days
Secondary	-Assessment of Head circumference	measurement of Head circumference weekly.	28 days
Secondary	-Assessment of length	-Assessment of length on admission and on discharge.	28 days