Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

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:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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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