Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

NCT05438680 | Completed DMC

• 1 other identifier: 0106797
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm

Keywords

Premature infants; colostrum; ROP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• prematurity related complications

  28 days

• Assessment of weight

  28 days

• -Assessment of Head circumference

  28 days

• -Assessment of length

  28 days

Study Arms (2)

Group I: bovine colostrum group

ACTIVE COMPARATOR

Dietary Supplement: The bovine colostrum ( trade name : baby steps sachets, 300mg )

group II : control group

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

The bovine colostrum ( trade name : baby steps sachets, 300mg ) DIETARY_SUPPLEMENT

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.

Group I: bovine colostrum group

Placebo DIETARY_SUPPLEMENT

distilled water with no bovine colostrum

group II : control group

Eligibility Criteria

• Age: 1 Hour - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life

You may not qualify if:

• Patients with any of the following will be excluded:
• Obvious major congenital abnormalities.
• Infants expected to be \>72 hours of age at the time of randomization.
• Parental consent lacking/refusal

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Alexandria university, Elshattbi hospital

Alexandria, 0354, Egypt

Location

Marwa Mohamed Farag

Alexandria, 0356, Egypt

Location

Related Publications (1)

• Farag MM, Thabet MAEH, Ahmed IS, Hanafi NF, Elsawy WS, Mohamed ES. Do preterm infants' retinas like bovine colostrum? A randomized controlled trial. Ital J Pediatr. 2024 Oct 19;50(1):218. doi: 10.1186/s13052-024-01781-z.

  PMID: 39427215 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mohamed Alaaaldin Thabet, PhD

  Faculty of medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Islam Shereen Hamdy, PhD

  Faculty of medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Eman Shabban Mohamed, MBBCh

  Faculty of medicine, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Marwa Mohamed Farag, PhD

  Faculty of medicine, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Model Details: Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 30, 2022
• Study Start: June 20, 2022
• Primary Completion: September 20, 2023
• Study Completion: October 1, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)