Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intestinal Colonization in Newborn Infants With Enterostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 8, 2017
First Posted Date November 13, 2017
Last Update Posted Date November 13, 2017
Actual Study Start Date June 21, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2017)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 8, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intestinal Colonization in Newborn Infants With Enterostomy
Official Title Proximal Remnant Intestinal Colonization in Newborn Infants With Enterostomy: a Longitudinal Study
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Enterostomy effluent
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.
Condition Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation
Intervention 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.
Study Groups/Cohorts Newborn infants with enterostomy
Infants with enterostomy after surgery due to congenital malformations of the gastrointestinal tract, necrotizing enterocolitis, and spontaneous intestinal perforation
Intervention: Procedure: Exposure(s) of interest: enterostomy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 8, 2017)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Portugal
Removed Location Countries  
 
Administrative Information
NCT Number NCT03340259
Other Study ID Numbers MICROENTE_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Universidade do Porto
Study Sponsor Universidade do Porto
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
Investigators
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
PRS Account Universidade do Porto
Verification Date July 2017