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Timing of Stoma Closure in Neonates

NCT04713579 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2023-01-18

No results posted yet for this study

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.

Conditions

  • Enterocolitis, Necrotizing
  • Atresia; Bowel
  • Gastroschisis
  • Meconium Ileus
  • Premature Birth
  • Bowel Obstruction
  • Perforation Bowel

Interventions

OTHER

No intervention - observational study

There is no intervention in this study as it is purely observational.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Nick Lansdale, MB FRCS PhD · Manchester University NHS Foundation Trust

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713579 on ClinicalTrials.gov