Last reviewed · How we verify
NCT06032676: NECqual
Qualitative Study of Surgeons With Prospective Patient Follow-up
trial in Necrotizing Enterocolitis in 75 participants. Currently enrolling.
1 October 2025
Quick facts
| Lead sponsor | University Hospital Southampton NHS Foundation Trust |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 75 |
| Start date | 1 January 2024 |
| Primary completion | 1 October 2025 |
| Estimated completion | 1 October 2028 |
| Sites | 1 location across United Kingdom |
Conditions studied
- Necrotizing Enterocolitis — all drugs for Necrotizing Enterocolitis →
Sponsor
University Hospital Southampton NHS Foundation Trust
Who can join
Under 4 Months, any sex, with Necrotizing Enterocolitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Necrotising enterocolitis (NEC) is a devastating disease which causes severe bowel inflammation resulting in babies becoming critically unwell. It mainly affects premature babies (who can be born as early as 22 weeks) in the first few weeks of life. A quarter of babies don't respond to intensive care treatment and require surgery to remove bowel which has died to prevent them from getting sicker. Sadly, about a third of the most unwell babies don't survive and those that do have a high incidence of significant long-term health problems. Deciding which babies will benefit from surgery is challenging and there are no objective methods used to do this currently. Surgeons must weigh up the risks and benefits of performing major surgery on a tiny baby in the knowledge that surgery itself may cause harm. This uncertainty causes delays in performing surgery. Those that have a delay are more likely to have a poor outcome. In order to improve these unfavourable outcomes it is essential to understand and define current practice in detail (i.e. indications and timing for surgery) and understand how this may be associated with outcome. These outcomes are both short term, including mortality and ability to tolerate enteral nutrition, and long term which include neurodevelopmental outcomes at 2 years of life. To do this the investigators will undertake a multicentre mixed methods study with qualitative interview of consultant paediatric surgeons shortly after making a decision to operate, or not, on a baby with NEC. The investigators will then take consent from the parents/guardian of the infant to follow-up their clinical outcomes using data linkage to routinely collected data, within the national neonatal research database. Outcomes of interest include survival, feeding outcomes, further surgical procedures and neurodevelopment at 2 years.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06032676
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Necrotizing Enterocolitis
Currently open trials in the same condition.
- NCT06681129 — Study of Normal Intestinal Development and Disease in Premature and Term Neonates · recruiting
- NCT06672913 — Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study · NA · recruiting
- NCT06908239 — Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants · NA · active not recruiting
- NCT05272579 — PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants · EARLY_PHASE1 · recruiting
- NCT05279664 — RIC-NEC Randomized Controlled Trial · Phase 2 · active not recruiting
Other University Hospital Southampton NHS Foundation Trust trials
Trials by the same sponsor.
- NCT07354971 — IMMUNO-FIT Observational Study · not yet recruiting
- NCT07278622 — Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial · NA · recruiting
- NCT07357558 — A Qualitative Study Investigating the Lived Experiences and Impact of Reproductive Issues in Adults With Primary Ciliary · recruiting
- NCT06851715 — Improving Quality of Life for Teenagers With Asthma · NA · recruiting
- NCT07489677 — The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among H · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06032676 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Southampton NHS Foundation Trust
- Last refreshed: 18 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06032676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing