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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

Completed Last updated 8 September 2025
What this trial tests

trial testing EMNODN NEC Care Bundle in Necrotising Enterocolitis Neonatal in 53,600 participants. Completed in 31 May 2025.

Timeline
1 December 2022
Primary endpoint
30 September 2024
31 May 2025

Quick facts

Lead sponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust
StatusCompleted
Study typeOBSERVATIONAL
Enrollment53,600
Start date1 December 2022
Primary completion30 September 2024
Estimated completion31 May 2025
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

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):

  1. 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

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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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