Clinical trial Recruiting at 1 site Observational Ages Any age to 4 Months

Understanding surgical decision-making for babies with necrotizing enterocolitis

Official title: Surgical Decision Making in Necrotising Enterocolitis - a Prospective Qualitative Study of Surgeons

Run by University Hospital Southampton NHS Foundation Trust · NCT06032676 · Data updated 2026-11-12

This study looks at how surgeons decide when to operate on premature babies with a serious bowel condition called necrotizing enterocolitis to help improve their chances of survival.

Quick facts

Study typeObservational
AgesAny age to 4 Months
SexAll
Enrollment75 (estimated)
SponsorUniversity Hospital Southampton NHS Foundation Trust
Academic / other
Locations1 site (Southampton, Hampshire)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedOctober 1, 2025
Study endsOctober 1, 2028
Registry record updatedApril 18, 2024
Trial IDNCT06032676 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants with suspected or confirmed necrotizing enterocolitis who are being evaluated by a surgeon.

Probably not a fit

Patients who are not undergoing surgical review or whose parents do not consent to follow-up will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the decision-making process of surgeons treating infants with necrotizing enterocolitis (NEC), a severe bowel condition primarily affecting premature babies. It aims to gather qualitative data on how surgeons assess the need for surgery in these critically ill infants, considering the high risks involved. By following up with patients post-surgery, the study seeks to identify patterns and improve outcomes for this vulnerable population. The ultimate goal is to develop more objective criteria for surgical intervention to reduce delays and improve survival rates.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical decision-making and better outcomes for infants suffering from necrotizing enterocolitis.

How similar studies have gone: While there have been studies on surgical decision-making in similar contexts, this specific qualitative approach to NEC is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • University Southampton NHS Foundation Trust
    Southampton, Hampshire, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.