Intestinal Colonization in Newborn Infants With Enterostomy

November 8, 2017 updated by: Universidade do Porto

Proximal Remnant Intestinal Colonization in Newborn Infants With Enterostomy: a Longitudinal Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1169-045
        • Recruiting
        • Neonatal Intensive Care Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central
        • Contact:
        • Contact:
        • Principal Investigator:
          • Conceição Calhau, PhD
        • Principal Investigator:
          • Luís Pereira-da-Silva, MD, PhD
        • Sub-Investigator:
          • Maria T Neto, MD, PhD
        • Sub-Investigator:
          • Gonçalo, C Ferreira, MD
        • Sub-Investigator:
          • Daniel Virella, MD, MSc
        • Sub-Investigator:
          • Ana Pita, MD
        • Sub-Investigator:
          • Ana Faria, PhD
        • Sub-Investigator:
          • Cláudia Marques, BsC
        • Sub-Investigator:
          • Inês B Mota, BsC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborn infants with enterostomy after surgery for CMGIT, NEC or SIP recruited at the NICU of Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisbon, Portugal.

Description

Inclusion criteria: newborn infants with enterostomy after surgery for CMGIT, NEC or SIP, consecutively admitted

Exclusion criteria: newborn infants with diagnosed inborn errors of metabolism, those whose parents or legal guardians will not consent to participate or withdrawn the consent, and those who had not complete 21 days of follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newborn infants with enterostomy
Infants with enterostomy after surgery due to congenital malformations of the gastrointestinal tract, necrotizing enterocolitis, and spontaneous intestinal perforation
Procedure: Exposure(s) of interest: enterostomy
Newborn infants with congenital malformations of the gastrointestinal tract, necrotizing enterocolitis, and spontaneous intestinal perforation commonly require surgery and enterostomy. In these infants samples of the enterostomy effluent will be collected and DNA extracted for microbiota identification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of postsurgical intestinal microbiota colonization specific to each underlying condition
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associations of types of microorganism identified with below defined clinical variables
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Universidade Nova de Lisboa
CINTESIS - Center for Health Technology and Services Research, Porto
Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa

Investigators

  • Principal Investigator: Luís Pereira-da-Silva, MD, PhD, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 21, 2017

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (ACTUAL)

November 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICROENTE_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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