NCT06534632

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: General Organization for Teaching Hospitals and Institutes · Academic / Other
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity

Interventions

Type	Name	Description
OTHER	Mother's colostrum	Oropharyngeal administration of mother's colostrum
OTHER	Placebo	Oropharyngeal administration of sterile water

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-10-30
• Completion: 2023-11-01
• First posted: 2024-08-02
• Last updated: 2024-08-05

Locations

1 site across 1 country: Egypt