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

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Other: Placebo; Other: Mother's colostrum

• Registration Number: NCT06534632
• Lead Sponsor: General Organization for Teaching Hospitals and Institutes

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-01
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	The placebo group received sterile water through the oropharyngeal route beginning in the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours
Colostrum group	Mother's colostrum	The interventional group received their mother's colostrum through the oropharyngeal route beginning within the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours

Primary Outcome Measures

Name	Time	Method
Number of infants with late-onset sepsis in each group	Up to 40 weeks corrected gestational age	Positive blood cultures collected or clinical symptoms of sepsis after 72 hours of age

Secondary Outcome Measures

Name	Time	Method
Mortality	Up to 40 weeks corrected gestational age	Number of deaths in each group

Trial Locations

Locations (1)

Mataria Teaching Hospital; 🇪🇬 Cairo, Egypt