Timing of Stoma Closure in Neonates (ToSCiN)

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Neonatologists in surgical NICUs, neonatal surgeons, neonatal dieticians and neonatal surgical nurses.

⁃ Workstream 2.1

• 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).

• Lead surgeons and neonatologists caring for infants recruited to WS 2.1.

⁃ Workstream 2.3

• 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.

Locations
Other Locations
United Kingdom
Manchester University NHS Foundation Trust
Manchester
Time Frame
Start Date: 2021-02-17
Completion Date: 2022-10-31
Participants
Target number of participants: 56
Treatments
Premature infants
Infants born prematurely requiring a stoma for condition such as necrotizing enterocolitis (NEC) or spontaneous intestinal perforation (SIP).
Term Infants
Infants born closer to term requiring a stoma e.g. for congenital causes of bowel obstruction such as intestinal atresia, gastroschisis or meconium ileus
Sponsors
Leads: Manchester University NHS Foundation Trust
Collaborators: University of Liverpool, University of Oxford

This content was sourced from clinicaltrials.gov

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