Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

Not Applicable

Completed

• Conditions: Prematurity

• Registration Number: NCT06459414
• Lead Sponsor: Cairo University

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.

Detailed Description

Oropharyngeal administration procedure using a standardized protocol, the doctor will provide the dosing as follows: two syringes will be warmed to room temperature. The first syringe's cap is removed and the tip of the syringe is gently placed into the neonate's mouth, alongside the right buccal mucosal tissue. The syringe tip is directed posteriorly towards the oropharynx, and the total volume (0.5 mL/kg) is slowly administered, over 20 seconds. The second syringe will be placed in the neonate's mouth in the same manner, but alongside the left buccal mucosal tissue. The entire volume (0.5 mL/kg) is administered slowly, over 20 seconds. A petite swab is used to carefully swab the right buccal mucosal tissue, followed by the left buccal mucosal tissue (≤5 seconds each side). A total volume of 1 mL/kg is administered per treatment, with buccal swabbing taking place over 10 seconds. Vital signs are carefully monitored throughout the procedure. Dosing is provided every 3 hours during the period of study.

Sample size will be 34 in each group, .

* Group A: receiving oropharyngeal colostrum for 10 days.

* Group B: control group receiving placebo for 10 days.

* Group C: receiving oropharyngeal colostrum for 3 days.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-04-15
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-14
• Primary Completion: 2024-07-29
• Status Verified: 2024-08
• Study Completion: 2024-08-17
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The difference in hospital length of stay between preterm neonates who received colostrum for 3 days and those who did not receive it	2 month	Determination of possible protective effects of colostrum via assessing the hospital stay

Trial Locations

Locations (1)

Hoda Atef Abdelsattar Ibrahim; 🇪🇬 Cairo, Egypt