Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

Prematurity Clinical Trial

Official title:

Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis and Late-onset Sepsis In Preterm Preterms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459414
• Other study ID #: MS-615-2022
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: Hoda Atef Abelsattar Ibrahim
• Phone: 01116344417
• Email: hodaibrahim424[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: July 30, 2024
• Est. primary completion date: July 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 2 Days

Eligibility

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).

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Prematurity

Intervention

Other:
• : Oropharyngeal Administration Of Colostrum or Saline
Preterm less than 34 weeks gestation will receive Oropharyngeal Colostrum for 3 days ( the first group) and for 10 days( the second group)

Locations

Country	Name	City	State
Egypt	Hoda Atef Abdelsattar Ibrahim	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of preterms who will develop necrotizing enterocolitis in each group	Determination of possible protective effects of colostrum via assessing the incidence of Necrotizing Enterocolitis and late-onset sepsis and other clinical outcomes as the hospital length of stay	1 month