Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation Clinical Trial
Official title:
Proximal Remnant Intestinal Colonization in Newborn Infants With Enterostomy: a Longitudinal Study
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | June 2020 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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with diagnosed inborn errors of metabolism, those whose parents or legal guardians will not consent to participate or withdrawn the consent, and those who had not complete 21 days of follow-up. |
| Country | Name | City | State |
|---|---|---|---|
| Portugal | Neonatal Intensive Care Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central | Lisbon |
| Lead Sponsor | Collaborator |
|---|---|
| Universidade do Porto | 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 |
Portugal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | 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. | 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 |