Actively Recruiting

Age: 0 - 4Months
All Genders
ID06032676

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

Age: 0 - 4Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

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

Diagnostic Evaluation

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

Surveillance

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

Long-term Monitoring

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

Loading map...

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

Similar Trials

PrePhage - Fecal Bacteriophage Transfer for Enhanced Gastroi...

Necrotizing Enterocolitis

Actively Recruiting

1 location

Probiotic Supplementation in Extremely Preterm Infants in Sc...

Necrotizing Enterocolitis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here