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

NCT06534632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-08-05

No results posted yet for this study

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

Interventions

OTHER

Mother's colostrum

Oropharyngeal administration of mother's colostrum

OTHER

Placebo

Oropharyngeal administration of sterile water

Sponsors & Collaborators

  • General Organization for Teaching Hospitals and Institutes

    lead OTHER

Principal Investigators

  • Marwa Taha, M.D. · Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt

  • Mai M Mostafa, M.D. · Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt

  • Fifi Helmy, M.D. · Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt

  • Sohaila A Abd El-Halim, M.D. · Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-10-30
Completion
2023-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534632 on ClinicalTrials.gov