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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02502916
Other study ID # PROBILAC/12O_2
Secondary ID
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


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
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