NCT06032676 Qualitative Study of Surgeons With Prospective Patient Follow-up
| NCT ID | NCT06032676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Condition | Necrotizing Enterocolitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2024-01-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Necrotising enterocolitis (NEC) is a devastating disease which causes severe bowel inflammation resulting in babies becoming critically unwell. It mainly affects premature babies (who can be born as early as 22 weeks) in the first few weeks of life. A quarter of babies don't respond to intensive care treatment and require surgery to remove bowel which has died to prevent them from getting sicker. Sadly, about a third of the most unwell babies don't survive and those that do have a high incidence of significant long-term health problems. Deciding which babies will benefit from surgery is challenging and there are no objective methods used to do this currently. Surgeons must weigh up the risks and benefits of performing major surgery on a tiny baby in the knowledge that surgery itself may cause harm. This uncertainty causes delays in performing surgery. Those that have a delay are more likely to have a poor outcome. In order to improve these unfavourable outcomes it is essential to understand and define current practice in detail (i.e. indications and timing for surgery) and understand how this may be associated with outcome. These outcomes are both short term, including mortality and ability to tolerate enteral nutrition, and long term which include neurodevelopmental outcomes at 2 years of life. To do this the investigators will undertake a multicentre mixed methods study with qualitative interview of consultant paediatric surgeons shortly after making a decision to operate, or not, on a baby with NEC. The investigators will then take consent from the parents/guardian of the infant to follow-up their clinical outcomes using data linkage to routinely collected data, within the national neonatal research database. Outcomes of interest include survival, feeding outcomes, further surgical procedures and neurodevelopment at 2 years.
Eligibility Criteria
Inclusion Criteria: 1. Infant with suspected or confirmed NEC undergoing review by surgeon, regardless of outcome of that review (I.e. surgery indicated or not). Exclusion Criteria: 2. Lack of consent from surgeon to undertake interview. 3. Lack of consent from parents to follow-up outcomes of infant.
Contact & Investigator
Nigel J Hall
PRINCIPAL INVESTIGATOR
University of Southampton
Frequently Asked Questions
Who can join the NCT06032676 clinical trial?
This trial is open to participants of all sexes, up to 4 Months, studying Necrotizing Enterocolitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06032676 currently recruiting?
Yes, NCT06032676 is actively recruiting participants. Contact the research team at g.s.bethell@soton.ac.uk for enrollment information.
Where is the NCT06032676 trial being conducted?
This trial is being conducted at Southampton, United Kingdom.
Who is sponsoring the NCT06032676 clinical trial?
NCT06032676 is sponsored by University Hospital Southampton NHS Foundation Trust. The principal investigator is Nigel J Hall at University of Southampton. The trial plans to enroll 75 participants.