Bovine Colostrum in Prevention of Retinopathy of Prematurity

• Sponsor: Alexandria University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05438680
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm	Dietary Supplement: The bovine colostrum ( trade name : baby steps sachets, 300mg ); Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effect of Bovine Colostrum in Prevention of Retinopathy of Prematurity
• Actual Study Start Date: May 20, 2021
• Anticipated Primary Completion Date: Feb 20, 2023
• Anticipated Study Completion Date: Mar 20, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. prematurity related complications [28 days]

   late onset sepsis IVH Necrotizing enterocolitis bronchopulmonary dysplasia

2. Assessment of weight [28 days]

   -Assessment of weight every other day.

3. -Assessment of Head circumference [28 days]

   measurement of Head circumference weekly.

4. -Assessment of length [28 days]

   -Assessment of length on admission and on discharge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Hour to 3 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marwa Mohamed Farag	Alexandria		Egypt	0356

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marwa Mohamed Farag, Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine, Alexandria University
• ClinicalTrials.gov Identifier: NCT05438680
• Other Study ID Numbers: 0106797
• First Posted: Jun 30, 2022
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marwa Mohamed Farag, Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine, Alexandria University: Premature infants; colostrum; ROP
• Additional relevant MeSH terms: Retinopathy of Prematurity

Study Results

No Results Posted as of Jun 30, 2022