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Intestinal Colonization in Newborn Infants With Enterostomy

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ClinicalTrials.gov Identifier: NCT03340259
Recruitment Status : Unknown
Verified July 2017 by Universidade do Porto.
Recruitment status was:  Recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
CINTESIS - Center for Health Technology and Services Research, Porto
Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa
NOVA Medical School, Universidade Nova de Lisboa
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation Procedure: Exposure(s) of interest: enterostomy

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Proximal Remnant Intestinal Colonization in Newborn Infants With Enterostomy: a Longitudinal Study
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Enterostomy effluent


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340259


Contacts
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Contact: Luís Pereira-da-Silva, MD, PhD +351 917235528 l.pereira.silva@nms.unl.pt
Contact: Conceição Calhau, PhD +351 218803000 ccalhau@nms.unl.pt

Locations
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Portugal
Neonatal Intensive Care Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central Recruiting
Lisbon, Portugal, 1169-045
Contact: Luís Pereira-da-Silva, MD, PhD    +351 917235528    l.pereira.silva@nms.unl.pt   
Contact: Inês B Mota, Student    +351 218 803 000    ines.mota@nms.unl.pt   
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         
Sponsors and Collaborators
Universidade do Porto
CINTESIS - Center for Health Technology and Services Research, Porto
Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa
NOVA Medical School, Universidade Nova de Lisboa
Investigators
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Principal Investigator: Luís Pereira-da-Silva, MD, PhD Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central
Principal Investigator: Conceição Calhau, PhD NOVA Medical School, Universidade Nova de Lisboa
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03340259    
Other Study ID Numbers: MICROENTE_01
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade do Porto:
Congenital malformations of the gastrointestinal tract
Enterostomy
Microbiota
Necrotizing enterocolitis
Newborn Infants
Spontaneous intestinal perforation
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Intestinal Perforation
Congenital Abnormalities
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases