Enteral Feeding and Early Gut Colonization of Preterm Infants (PRECOL)

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth of Newborn

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 Type: Observational
• Enrollment (Actual): 32

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 hours to 8 hours (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants born from October 2009 to June 2010 at the Hospital 12 de Octubre with a gestational age of less than 32 weeks or with birth weight of less than 1,200 g

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Preterm infant; Preterm infants born from October 2009 to June 2010 at a gestational age of less than 32 weeks or with birth weight of less than 1,200 g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Juan M Rodriguez, PhD, Universidad Complutense Madrid

Publications and helpful links

General Publications

• Gomez M, Moles L, Melgar A, Ureta N, Bustos G, Fernandez L, Rodriguez JM, Jimenez E. Early Gut Colonization of Preterm Infants: Effect of Enteral Feeding Tubes. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):893-900. doi: 10.1097/MPG.0000000000001104.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 12, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Estimate): July 20, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PROBILAC/12O_2