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

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.

Study Overview

• Status: Completed
• Conditions: Preterm
• Intervention / Treatment: Dietary supplement: The bovine colostrum ( trade name : baby steps sachets, 300mg ); Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 0356
    • Marwa Mohamed Farag
  • Alexandria, Egypt, 0354
    • Alexandria university, Elshattbi hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 3 days (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: bovine colostrum group	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 Comparator: group II : control group	Dietary supplement: Placebo; distilled water with no bovine colostrum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Mohamed Alaaaldin Thabet, PhD, Faculty of Medicine, Alexandria University, Egypt; Study Director: Islam Shereen Hamdy, PhD, Faculty of Medicine, Alexandria University, Egypt; Principal Investigator: Eman Shabban Mohamed, MBBCh, Faculty of Medicine, Alexandria University, Egypt; Study Chair: Marwa Mohamed Farag, PhD, Faculty of Medicine, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 25, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ROP; colostrum; Premature infants
• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Retinal Diseases; Infant, Premature, Diseases; Retinopathy of Prematurity
• Other Study ID Numbers: 0106797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No