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NCT05934123: EMNODN-NEC
Effects of Implementation of a Care Bundle on Rates of NEC and Own Mother's Milk Feeding in the East Midlands
trial testing EMNODN NEC Care Bundle in Necrotising Enterocolitis Neonatal in 53,600 participants. Completed in 31 May 2025.
30 September 2024
Quick facts
| Lead sponsor | University Hospitals of Derby and Burton NHS Foundation Trust |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 53,600 |
| Start date | 1 December 2022 |
| Primary completion | 30 September 2024 |
| Estimated completion | 31 May 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- EMNODN NEC Care Bundle
Conditions studied
- Necrotising Enterocolitis Neonatal — all drugs for Necrotising Enterocolitis Neonatal →
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Who can join
Eligibility, any sex, with Necrotising Enterocolitis Neonatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Necrotising enterocolitis (NEC) is a life-threatening gut disease in babies born early. Feeding preterm babies their own mother's milk prevents NEC. Fewer babies in the East Midlands get their own mother's milk than the national average, and more babies get NEC. The East Midlands Neonatal Operational Delivery Network (EMNODN) has created a care bundle to increase own mothers' milk feeding and reduce rates of NEC among babies born more than 8 weeks early, who are at the greatest risk of NEC. The care bundle describes the support that parents can expect to receive to help mothers feed their breastmilk to their babies. It also provides guidelines to help neonatal units ensure babies receive optimum nutritional care. This study will find whether this bundle is effective in helping more babies receive their own mothers' milk and in reducing NEC. It will also identify how well the bundle was introduced and which parts of the bundle were most helpful. The study team will answer these questions by collecting and studying data from babies' medical records.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of implementation of a care bundle on rates of necrotising enterocolitis and own mother's milk feeding in the East Midlands: protocol for a mixed methods impact and process evaluation study.
Abramson J, Szatkowski L, Bains M, Orton E, et al · · 2024 · cited 4× · PMID 38816042 · DOI 10.1136/bmjopen-2023-078633
Verify or expand the search:
- PubMed search for NCT05934123
- Europe PMC full search
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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 NCT05934123 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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 Hospitals of Derby and Burton NHS Foundation Trust
- Last refreshed: 8 September 2025
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/NCT05934123.
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