Intestinal Colonization in Newborn Infants With Enterostomy

NCT03340259 | Unknown

• 1 other identifier: MICROENTE_01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Congenital malformations of the gastrointestinal tract; Enterostomy; Microbiota; Necrotizing enterocolitis; Newborn Infants; Spontaneous intestinal perforation

Outcome Measures

Primary Outcomes (1)

• Pattern of postsurgical intestinal microbiota colonization specific to each underlying condition

  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 Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Exposure(s) of interest: enterostomy PROCEDURE

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.

Newborn infants with enterostomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Neonatal Intensive Care Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central

Lisbon, 1169-045, Portugal

RECRUITING

Related Publications (1)

• Barreiros Mota I, Marques C, Faria A, Neto MT, Cordeiro-Ferreira G, Virella D, Pita A, Pereira-da-Silva L, Calhau C. Colonisation of the proximal intestinal remnant in newborn infants with enterostomy: a longitudinal study protocol. BMJ Open. 2019 Nov 24;9(11):e028916. doi: 10.1136/bmjopen-2019-028916.

  PMID: 31767579 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Enterostomy effluent

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Luís Pereira-da-Silva, MD, PhD

  Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central

  PRINCIPAL INVESTIGATOR

• Conceição Calhau, PhD

  Universidade Nova de Lisboa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luís Pereira-da-Silva, MD, PhD

CONTACT

+351 917235528; l.pereira.silva@nms.unl.pt

Conceição Calhau, PhD

CONTACT

+351 218803000; ccalhau@nms.unl.pt

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: June 21, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)