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Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

NCT06459414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-08-28

No results posted yet for this study

Summary

Mother's milk samples will be collected during the routine expression of milk, using a hospital-grade electric breast pump, and will be stored in the NICU breastmilk refrigerator. The research doctor will prepare the syringes for the first 24 hours of the Initial Treatment Period. For neonates in the placebo group, the milk is immediately frozen, in a separate NICU breastmilk freezer to maintain blinding, for later use when enteral feedings are started. Using sterile gloves, oral syringes will be each filled with 1 mL/kg of colostrum or normal saline 0.9% (based on group assignment), capped, and covered with a white tape as a blinding procedure. Each syringe will be labeled with the patient's name, medical record number, and the date and time of preparation. Syringes will be prepared in the same sterile manner, by the research doctor, every 24 hours.

Conditions

  • Prematurity

Interventions

OTHER

: Oropharyngeal Administration Of Colostrum

Preterm less than 34 weeks gestation will receive Oropharyngeal Colostrum for 3 days ( the first group) and for 10 days( the second group)

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Iman Eiada · Professor of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2024-07-29
Completion
2024-08-17

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 NCT06459414 on ClinicalTrials.gov