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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06459414
Other study ID # MS-615-2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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