Status:
COMPLETED
Timing of Stoma Closure in Neonates
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
University of Oxford
University of Liverpool
Conditions:
Enterocolitis, Necrotizing
Atresia; Bowel
Eligibility:
All Genders
Brief Summary
Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage ...
Detailed Description
Neonates undergoing emergency abdominal surgery frequently require stoma formation. Reversing (closing) these stomas with a second operation is an essential part of the infant's recovery. The timing o...
Eligibility Criteria
Inclusion
- Workstream 1
- Inclusion criteria:
- Neonatologists in surgical NICUs, neonatal surgeons, neonatal dieticians and neonatal surgical nurses.
- Workstream 2.1
- Inclusion criteria:
- Infants having a stoma as part of emergency surgery before 44 weeks post-conceptual age: Group A preterm infants who have stomas formed for necrotising enterocolitis, spontaneous intestinal perforation or other intestinal pathology, and Group B infants (usually born closer to term) who have congenital anomalies that lead to bowel obstruction (e.g. intestinal atresias; meconium ileus and other conditions such as complicated gastroschisis).
- Exclusion criteria:
- Cases where a stoma is part of a planned treatment pathway e.g. for an anorectal malformation or Hirschsprung's disease.
- Infants who have a stoma formed after 44 weeks post-conceptual age.
- Workstream 2.2
- Inclusion criteria:
- Lead surgeons and neonatologists caring for infants recruited to WS 2.1.
- Workstream 2.3
- Inclusion criteria:
- Parents of premature and term infants who have had an stoma in the last three years (including parents of infants recruited to WS 2.1).
- Clinicians in participating surgical units, who are involved in the treatment of infants requiring emergency stoma closure.
- Exclusion criteria:
- Parents who do not speak English.
Exclusion
Key Trial Info
Start Date :
February 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04713579
Start Date
February 17 2021
End Date
October 31 2022
Last Update
January 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Manchester University NHS Foundation Trust
Manchester, United Kingdom