Enteral Feeding and Early Gut Colonization of Preterm Infants

Premature Birth of Newborn Clinical Trial

— PRECOL  

Official title:

Potential Role of the Enteral Feeding Systems on Early Bacterial Gut Colonization of Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502916
• Other study ID #: PROBILAC/12O_2
• Status: Completed
• Phase: N/A
• First received: July 12, 2015
• Last updated: July 16, 2015
• Start date: October 2009
• Est. completion date: July 2012

Study information

• Verified date: July 2015
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Hours

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Premature Birth of Newborn

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infants sharing bacterial strains with the milk received by each one	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.	two years	No
Secondary	Number of bacterial strains shared by each infant and the milk received.	In each infant the number of the same bacterial strains isolated from fecal samples and milk received have been determined.	two years	No