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Completed

NCT Number: NCT05438680

Bovine Colostrum in Prevention of 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.

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Key information

Conditions

Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria university, Elshattbi hospital, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Dietary Supplement

distilled water with no bovine colostrum

Primary outcomes

  1. Fundus examination to detect retinopathy of prematurity

    Time frame: 28 days

    ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease

Secondary outcomes

  1. prematurity related complications

    Time frame: 28 days

    • late onset sepsis
    • IVH
    • Necrotizing enterocolitis
    • bronchopulmonary dysplasia

  2. Assessment of weight

    Time frame: 28 days

    -Assessment of weight every other day.

  3. -Assessment of Head circumference

    Time frame: 28 days

    measurement of Head circumference weekly.

  4. -Assessment of length

    Time frame: 28 days

    -Assessment of length on admission and on discharge.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of the Effect of Bovine Colostrum in Prevention of Late Onset Sepsis and Retinopathy of Prematurity

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2022
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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