Enteral Feeding and Early 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.

Completed

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Key information

Conditions

Premature Birth of Newborn Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 hour–8 hour

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of infants sharing bacterial strains with the milk received by each one

Time frame: 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 outcomes

Number of bacterial strains shared by each infant and the milk received.

Time frame: two years

In each infant the number of the same bacterial strains isolated from fecal samples and milk received have been determined.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: PRECOL

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2012
First posted: Jul 20, 2015
Registry last updated: Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed