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
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|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
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.
- 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
- 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
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
|Contact: Luís Pereira-da-Silva, MD, PhD||+351 firstname.lastname@example.org|
|Contact: Conceição Calhau, PhD||+351 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Inês B Mota, Student +351 218 803 000 email@example.com|
|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|
|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|