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

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.

Study Overview

• Status: Completed
• Conditions: Prematurity
• Intervention / Treatment: Other: Mother's colostrum; Other: 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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Mataria Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colostrum group; 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	Other: Mother's colostrum; Oropharyngeal administration of mother's colostrum
Placebo Comparator: Placebo group; 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	Other: Placebo; Oropharyngeal administration of sterile water

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of deaths in each group	Up to 40 weeks corrected gestational age

Collaborators and Investigators

• Sponsor: General Organization for Teaching Hospitals and Institutes
• Investigators: Principal Investigator: Marwa Taha, M.D., Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt; Study Director: Mai M Mostafa, M.D., Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt; Study Director: Fifi Helmy, M.D., Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt; Study Director: Sohaila A Abd El-Halim, M.D., Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: HM000142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No