Clinical trial NCT03340259: Intestinal Colonization in Newborn Infants With Enterostomy
Official title: Proximal Remnant Intestinal Colonization in Newborn Infants With Enterostomy: a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation
Keywords: Congenital malformations of the gastrointestinal tract
Enterostomy
Microbiota
Necrotizing enterocolitis
Newborn Infants
Spontaneous intestinal perforation
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: CINTESIS - Center for Health Technology and Services Research, Porto
name: Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa
name: Universidade Nova de Lisboa
First posted: 2017-11-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Pattern of postsurgical intestinal microbiota colonization specific to each underlying condition
timeFrame: 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
Secondary outcomes:
measure: Associations of types of microorganism identified with below defined clinical variables
timeFrame: 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
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Neonatal Intensive Care Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central
Study officials:
affiliation: Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central
name: Luís Pereira-da-Silva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Nova de Lisboa
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.