Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459414
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2024-04-29
Brief Title:
Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis and Late-onset Sepsis In Preterm Preterms
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mothers 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 mLkg of colostrum or normal saline 09 based on group assignment capped and covered with a white tape as a blinding procedure Each syringe will be labeled with the patients 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 syringes cap is removed and the tip of the syringe is gently placed into the neonates mouth alongside the right buccal mucosal tissue The syringe tip is directed posteriorly towards the oropharynx and the total volume 05 mLkg is slowly administered over 20 seconds The second syringe will be placed in the neonates mouth in the same manner but alongside the left buccal mucosal tissue The entire volume 05 mLkg 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 mLkg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None