Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

A

Alexandria University

Status

Completed

Conditions

Preterm

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05438680
0106797

Details and patient eligibility

About

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.

Full 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: First phase: Enrollment and selection phase. Second phase: Intervention phase ( enteral bovine colostrum administration) . Third phase: Evaluation phase. Fourth phase: collected data analysis and results.

Enrollment

200 patients

Sex

All

Ages

1 hour to 3 days old

Volunteers

No Healthy Volunteers

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:

  • Obvious major congenital abnormalities.
  • Infants expected to be >72 hours of age at the time of randomization.
  • Parental consent lacking/refusal

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups, including a placebo group

Group I: bovine colostrum group
Active Comparator group
Treatment:
Dietary Supplement: The bovine colostrum ( trade name : baby steps sachets, 300mg )
group II : control group
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

2

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Central trial contact

Eman shabban Mohamed, MBBCh; Marwa mohamed Farag, PhD

Data sourced from clinicaltrials.gov

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