Understanding surgical decision-making for babies with necrotizing enterocolitis
Surgical Decision Making in Necrotising Enterocolitis - a Prospective Qualitative Study of Surgeons
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 |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | N/A to 4 Months |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Locations | 1 site (Southampton, Hampshire) |
| Trial ID | NCT06032676 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants with suspected or confirmed necrotizing enterocolitis who are being evaluated by a surgeon.
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.
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 performed: While there have been studies on surgical decision-making in similar contexts, this specific qualitative approach to NEC is relatively novel.
Eligibility criteria
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 this trial is running
Southampton, Hampshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.