Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

NCT ID: NCT06459414

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-08-17

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.

Conditions

Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Interventional group recieveing Oropharyngeal Of Colostrum for 3 days

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

Group Type: EXPERIMENTAL

: Oropharyngeal Administration Of Colostrum

Intervention Type: OTHER

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

Interventional group recieveing Oropharyngeal Of Colostrum for 10 days

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

Group Type: EXPERIMENTAL

: Oropharyngeal Administration Of Colostrum

Intervention Type: OTHER

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

Control group recieving only the standard care

The control group will receive only the standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

: 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)

Intervention Type: OTHER

Other Intervention Names

Oropharyngeal Administartion of Colostrum

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hoda Atef Abdelsattar Ibrahim

Lectuere of Pediatrics and Pediatric Clinical Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iman Eiada

Role: PRINCIPAL_INVESTIGATOR

Professor of Pediatrics

Locations

Hoda Atef Abdelsattar Ibrahim

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-615-2022

Identifier Type: -

Identifier Source: org_study_id