Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT02502916
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
2015-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteral Feeding and Early Gut Colonization of Preterm Infants
Sponsor:
Universidad Complutense de Madrid
Organization:
Study Overview
Official Title:
Potential Role of the Enteral Feeding Systems on Early Bacterial Gut Colonization of Preterm Infants
Status:
COMPLETED
Status Verified Date:
2015-07
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:
PRECOL
Brief Summary:
The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.
Detailed Description:
First spontaneously evacuated meconium and fecal samples were collected by the medical staff of the Hospital weekly from the diapers of the infants during their stay at the Neonatal Intensive Care Unit.
To evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured.
Later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.
To evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured.
Later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.
Study Oversight
Has Oversight DMC:
False
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?: