Enteral Feeding and Early Gut Colonization of Preterm Infants

NCT02502916 | Completed

• 1 other identifier: PROBILAC/12O_2
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature Birth of Newborn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  two years

Study Arms (1)

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

Eligibility Criteria

• Age: 2 Hours - 8 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• any malformation or suffering from any genetic metabolic disorder

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Related Publications (1)

• 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.

  PMID: 26741949 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

meconium, fecal samples mother's milk donor's milk

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Juan M Rodriguez, PhD

  Universidad Complutense Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 20, 2015
• Study Start: October 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2012
• Last Updated: July 20, 2015

Record last verified: 2015-07