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 type | Observational |
|---|---|
| Ages | Any age to 4 Months |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Locations | 1 site (Southampton, Hampshire) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2028 |
| Registry record updated | April 18, 2024 |
| Trial ID | NCT06032676 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
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University Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom Recruiting
Study contacts
- Principal investigator: Nigel J Hall — University of Southampton
- Study coordinator: George S Bethell
- Email: g.s.bethell@soton.ac.uk
- Phone: +442381206146
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This project will collect intestinal tissue from newborns and infants up to age 2 who have GI surgery or biopsies to see how the human intestine develops and how conditions like NEC affect it.
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This study is testing if a new treatment called ST266 can help infants with Necrotizing Enterocolitis feel better when given along with their usual care.
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This study is testing if giving probiotics mixed with breastmilk can help extremely preterm infants avoid serious gut problems and reduce the risk of dying.
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This study is testing if giving preterm infants healthy gut bacteria from full-term babies can help improve their gut health and prevent serious digestive problems.
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Withholding enteral feeds during blood transfusions in premature infants
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.