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Effects of Implementation of a Care Bundle on Rates of NEC and Own Mother's Milk Feeding in the East Midlands

NCT05934123 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53600

Last updated 2025-09-08

No results posted yet for this study

Summary

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.

Conditions

  • Necrotising Enterocolitis Neonatal

Interventions

BEHAVIORAL

EMNODN NEC Care Bundle

A care bundle created by the East Midlands Neonatal Operational Delivery Network to guide neonatal services in the region to implement practices that support own mother's milk feeding and other interventions that may reduce the risk of NEC in babies born \<32 weeks' gestational age.

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • University Hospitals of Derby and Burton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Shalini Ojha, PhD · University of Nottingham

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-09-30
Completion
2025-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05934123 on ClinicalTrials.gov