Intestinal Colonization in Newborn Infants With Enterostomy

• Conditions: Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation

• Registration Number: NCT03340259
• Lead Sponsor: Universidade do Porto

Brief Summary

The human microbiota, a collection of microorganisms mostly settled in the gastrointestinal tract, plays a major role in the maintenance of the hosts' health and in development of disease as well. Exposure to different conditions early in life contributes to distinct "pioneer" bacterial communities, which shape the newborn infants' development and influence their later physiological, immunological and neurological homeostasis. Newborn infants with congenital malformations of the gastrointestinal tract (CMGIT), necrotizing enterocolitis (NEC), and spontaneous intestinal perforation (SIP) commonly require abdominal surgery and enterostomy. While intestinal microbiota has been extensively studied in infants with anatomically uninterrupted intestine, the knowledge of longitudinal intestinal colonization in this population is scarce.

This is an exploratory, observational, and longitudinal prospective study, primarily aimed to determine longitudinally the colonization of the proximal remnant intestine, in newborn infants with enterostomy after surgery (three weeks) for CMGIT, NEC and SIP. The secondary aim is to explore the associations of the colonization with the mode of delivery, gestational age, postnatal age, duration of fasting, type of enteric feeding, antimicrobial therapy, H2-receptor antagonist therapy, and length of proximal remnant intestine.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-21
• Status Verified: 2017-07
• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Last Update Submitted: 2017-11-08
• Study First Posted: 2017-11-13
• Last Update Posted: 2017-11-13
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pattern of postsurgical intestinal microbiota colonization specific to each underlying condition	The first sample will be collected as close as possible after placement of ostomy bag. From the first collection, new samples will be collected every 3 days, until the 21st day after surgery	Longitudinal postsurgical microbiota colonization of the proximal remnant intestine, specific to each underlying condition

Secondary Outcome Measures

Name	Time	Method
Associations of types of microorganism identified with below defined clinical variables	The aforementioned clinical variables will be collected daily and the enterostomy effluent collected from the first placement of ostomy bag and every 3 days thereafter up to 21 days after surgery	Associations of microbiota colonization with the mode of delivery, gestational age, postnatal age, duration of fasting, type of enteric feeding, antimicrobial therapy, H2-receptor antagonist therapy, and length of proximal remnant intestine.

Trial Locations

Locations (1)

Neonatal Intensive Care Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central; 🇵🇹 Lisbon, Portugal