Enteral Feeding and Early Gut Colonization of Preterm Infants

Completed

• Conditions: Premature Birth of Newborn

• Registration Number: NCT02502916
• Lead Sponsor: Universidad Complutense de Madrid

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-06
• Study Completion: 2012-07
• Status Verified: 2015-07
• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-16
• Last Update Submitted: 2015-07-16
• Study First Posted: 2015-07-20
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• gestational age of less than 32 weeks or with birth weight of less than 1,200 g

Exclusion Criteria

• any malformation or suffering from any genetic metabolic disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of infants sharing bacterial strains with the milk received by each one	two years	The meconium and fecal samples of the infants have been analysed microbiologically. In parallel, own's mother milk, donor milk and formula milk have been analyzed microbiologically after their pass through the nasogastric feeding tube. The bacterial strains isolated from fecal samples of each infant have been compared with the bacterial strains isolated from the milk that have received each of them.

Secondary Outcome Measures

Name	Time	Method
Number of bacterial strains shared by each infant and the milk received.	two years	In each infant the number of the same bacterial strains isolated from fecal samples and milk received have been determined.