Actively Recruiting
Surgical Decision Making in Necrotising Enterocolitis: A Prospective Qualitative Study of Surgeons with Patient Outcome Follow-Up
Led by University Hospital Southampton NHS Foundation Trust · Updated on 2024-04-18
75
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Necrotising enterocolitis (NEC) is a serious bowel inflammation mainly affecting premature babies, often within the first few weeks of life. This condition can lead to critical illness, with some infants requiring surgery to remove dead bowel tissue. Unfortunately, many babies do not survive or experience long-term health challenges. Surgeons face difficulties deciding when surgery is needed, as delays or premature operations can worsen outcomes. This observational study aims to understand current surgical decision-making and how it relates to baby outcomes, including survival and development at 2 years. The study involves interviewing consultant paediatric surgeons about their decision-making after reviewing infants suspected or confirmed to have NEC. Parents are asked for consent to follow up their infants' health through data linkage with a national neonatal database. The study tracks infants from initial surgical review through hospital discharge and up to two years of age, focusing on survival, feeding ability, further surgeries, and neurodevelopment. Participants will be involved through interviews with surgeons and consent for outcome follow-up. Data collected includes detailed clinical information from routine neonatal records. Researchers will analyze survival rates at 52 weeks corrected gestational age and again at 2 years, along with nutritional dependence and neurodevelopmental outcomes. This comprehensive approach aims to link surgical decisions with short- and long-term infant health results.
CONDITIONS
Brief Title
Qualitative Study of Surgeons With Prospective Patient Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant with suspected or confirmed necrotising enterocolitis (NEC) undergoing review by a consultant surgeon, regardless of surgery decision
- Parents or guardians provide consent for follow-up of infant outcomes
You will not qualify if you...
- Surgeon does not consent to participate in interviews
- Parents or guardians do not consent to follow-up of infant outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for clinical review by a consultant surgeon
Duration - Occurs at clinical review visit
Participants undergo a clinical review by a consultant surgeon to consider the need for surgery for necrotising enterocolitis (NEC).
1 visit (in-person) for clinical review and surgeon interview
Duration - Up to 52 weeks corrected gestational age
Participants are observed through routine data collection linked to the National Neonatal Research Database (NNRD) to monitor short-term outcomes including survival, nutritional status, and surgery decisions.
Data collected through routine healthcare records; no additional visits required
Duration - Up to 2 years of age
Participants' health and development are monitored through follow-up data collection at 2 years of age focusing on neurodevelopmental outcomes and cerebral palsy diagnosis.
Data collected through routine healthcare records; no additional visits required
Trial Site Locations
Total: 1 location
1
University Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
G
George S Bethell
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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