Timing of Stoma Closure in Neonates (NCT04713579) | Clinical Trial Compass
CompletedNot Applicable
Timing of Stoma Closure in Neonates
United Kingdom56 participantsStarted 2021-02-17
Plain-language 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 of the bowel. As part of this surgery, the ends of the bowel may be brought to the skin surface (called a stoma) to divert stool into a bag. The stoma allows time for the bowel to rest and recover and is intended to be temporary with reversal later on. The best time to reverse or "close" the stoma is unknown. Stomas may cause dehydration, poor growth and skin problems so earlier closure may be better; however surgery is safer when babies are older and bigger so later closure may be better.
This study aims to answer the question, 'is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' It has a series of specific objectives which incorporate: (i) describing current UK practice; (ii) establishing whether or not a clinical trial (and exactly what form of trial) is acceptable to parents and clinicians; and (iii) establishing the design of a potential trial, including defining the intervention ('early vs. late') and the population of infants to be included, how infants should be recruited and what information should be collected (outcomes).
The investigators will ask parents and health professionals for their views and whether they would take part in a future trial and information about babies who have recently had a stoma to find out which factors influence the timing of closure. They will also analyse 6 years of data from an existing database, the National Neonatal Research Database to estimate the numbers of babies affected, understand current practice and outcomes for these babies to help decide whether a clinical trial is possible.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of a future trial comparing early and late stoma closure
Timeframe: through study completion, an average of 1 year