Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

NCT06459414 | Completed

• 1 other identifier: MS-615-2022
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The difference in hospital length of stay between preterm neonates who received colostrum for 3 days and those who did not receive it

  Determination of possible protective effects of colostrum via assessing the hospital stay

  2 month

Study Arms (3)

Interventional group recieveing Oropharyngeal Of Colostrum for 3 days

EXPERIMENTAL

The first interventional group will receive colostrum of their mother's breast milk through oropharyngeal route for 3 days on 1 ml/kg/day

Other: : Oropharyngeal Administration Of Colostrum

Interventional group recieveing Oropharyngeal Of Colostrum for 10 days

EXPERIMENTAL

The second interventional group will receive colostrum of their mother's breast milk through oropharyngeal route for 10 days on 1 ml/kg/day

Other: : Oropharyngeal Administration Of Colostrum

Control group recieving only the standard care

NO INTERVENTION

The control group will receive only the standard care

Interventions

: Oropharyngeal Administration Of Colostrum OTHER

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

Also known as: Oropharyngeal Administartion of Colostrum

Interventional group recieveing Oropharyngeal Of Colostrum for 10 days; Interventional group recieveing Oropharyngeal Of Colostrum for 3 days

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with gestational age (GA) ≤ 34 weeks at birth
• Neonates who will be in admitted in the neonatal intensive care unit (NICU) within 48 hours after birth.

You may not qualify if:

• Any contraindication for breastfeeding as mother-related (e.g. Mothers prohibited from breastfeeding because of conditions including active tuberculosis or AIDS, treatment with radioisotopes (e.g., Iodine-131, Cobalt-60, Cesium-137) and substance abuse)
• Also any contraindication for breastfeeding as infant-related (Birth complicated with severe gastrointestinal malformations).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hoda Atef Abdelsattar Ibrahim

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

• Iman Eiada

  Professor of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lectuere of Pediatrics and Pediatric Clinical Nutrition

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: June 14, 2024
• Study Start: April 15, 2024
• Primary Completion: July 29, 2024
• Study Completion: August 17, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

EG (1)