An observational study in Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation, sponsored by Universidade do Porto. Status unknown at 1 site in Portugal. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by Universidade do Porto · Observational
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 30 is below the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Universidade do Porto is the lead sponsor of 174 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
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
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
Associations of types of microorganism identified with below defined clinical variables
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.
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
Plan to share: No
Started Jun 2017 (actual). Primary completion is estimated for Jun 2020, 36 months after the start.
Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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