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

NCT06534632 | Completed

• 1 other identifier: HM000142
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mortality

  Up to 40 weeks corrected gestational age

Study Arms (2)

Colostrum group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Mother's colostrum OTHER

Oropharyngeal administration of mother's colostrum

Colostrum group

Placebo OTHER

Oropharyngeal administration of sterile water

Placebo group

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Organization for Teaching Hospitals and Institutes: lead

Study Sites (1)

Mataria Teaching Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Marwa Taha, M.D.

  Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow of Pediatrics (Principal Investigator)

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: November 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: November 1, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

EG (1)