Intestinal Colonization in Newborn Infants With Enterostomy
NCT ID: NCT03340259
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2017-06-21
2020-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Newborn infants with enterostomy
Infants with enterostomy after surgery due to congenital malformations of the gastrointestinal tract, necrotizing enterocolitis, and spontaneous intestinal perforation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
ALL
No
Sponsors
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CINTESIS - Center for Health Technology and Services Research, Porto
UNKNOWN
Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa
UNKNOWN
Universidade Nova de Lisboa
OTHER
Universidade do Porto
OTHER
Responsible Party
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Principal Investigators
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Luís Pereira-da-Silva, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central
Conceição Calhau, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Nova de Lisboa
Locations
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Neonatal Intensive Care Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central
Lisbon, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Luís Pereira-da-Silva, MD, PhD
Role: primary
Inês B Mota, Student
Role: backup
References
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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.
Other Identifiers
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MICROENTE_01
Identifier Type: -
Identifier Source: org_study_id