Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534632
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Does Oral Care With Mothers Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aimed to evaluate the efficacy of the oral mothers colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit The investigators hypothesized that premature infants who receive oral mothers colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes compared to infants who receive a placebo
Detailed Description:
The study was a randomized clinical trial performed on very-low-birthweight premature newborns admitted to the neonatal intensive care unit of Mataria Teaching Hospital after considering exclusion criteria
The enrolled newborns were randomly subdivided into two groups 11 The colostrum group received their mothers colostrum and the placebo group received placebo sterile water using a standardized protocol The newborns received 02 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx 01 mL on either side of the oral cavity starting during the first 24 hours of life and lasting for 5 days Vital signs were carefully monitored throughout the procedure Dosing was provided every 6 hours during the study period
All infants underwent follow-up from birth until discharge or death whichever came first Neonates were evaluated for occurrence of late-onset sepsis death and other clinical outcomes
The enrolled newborns were randomly subdivided into two groups 11 The colostrum group received their mothers colostrum and the placebo group received placebo sterile water using a standardized protocol The newborns received 02 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx 01 mL on either side of the oral cavity starting during the first 24 hours of life and lasting for 5 days Vital signs were carefully monitored throughout the procedure Dosing was provided every 6 hours during the study period
All infants underwent follow-up from birth until discharge or death whichever came first Neonates were evaluated for occurrence of late-onset sepsis death and other clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None