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Completed

NCT Number: NCT06534632

Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants

This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. The investigators hypothesized that premature infants who receive oral mother's colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes, compared to infants who receive a placebo.

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Key information

Age range

1 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mataria Teaching Hospital

Cairo, Egypt

About this study

The study was a randomized clinical trial, performed on very-low-birthweight premature newborns admitted to the neonatal intensive care unit of Mataria Teaching Hospital after considering exclusion criteria.

The enrolled newborns were randomly subdivided into two groups (1:1). The colostrum group received their mother's colostrum, and the placebo group received placebo (sterile water) using a standardized protocol. The newborns received 0.2 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx (0.1 mL on either side of the oral cavity), starting during the first 24 hours of life and lasting for 5 days. Vital signs were carefully monitored throughout the procedure. Dosing was provided every 6 hours during the study period.

All infants underwent follow-up from birth until discharge or death whichever came first. Neonates were evaluated for occurrence of late-onset sepsis, death, and other clinical outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Very-low-birth-weight preterm newborns admitted to the neonatal intensive care unit within 24 hours after delivery
  • Neonates with gestational age ≤ 34 weeks and weight ≤ 1500 grams

Exclusion criteria

  • Infants with severe gastrointestinal malformations.
  • Infants with serious congenital anomalies or chromosomal abnormalities.
  • Infants with signs of early-onset sepsis.
  • Any contraindications for breastfeeding because of maternal conditions including active tuberculosis or AIDS, or treatment with medications excreted in breast milk.

Treatment and study plan

Mother's colostrum

Other

Oropharyngeal administration of mother's colostrum

Placebo

Other

Oropharyngeal administration of sterile water

Primary outcomes

  1. Number of infants with late-onset sepsis in each group

    Time frame: Up to 40 weeks corrected gestational age

    Positive blood cultures collected or clinical symptoms of sepsis after 72 hours of age

Secondary outcomes

  1. Mortality

    Time frame: Up to 40 weeks corrected gestational age

    Number of deaths in each group

Sponsors and collaborators

Lead sponsor

General Organization for Teaching Hospitals and Institutes

Other

Registry information

Official study title

Does Oral Care With Mother's Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2024
Registry last updated
Aug 5, 2024

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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