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

NCT05934123 | Completed

• 1 other identifier: UHDB/2021/059
• Study Type: observational
• Target: 53,600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breastfeeding; Necrotising enterocolitis; Care bundle

Outcome Measures

Primary Outcomes (3)

• Receiving any own mother's milk at discharge

  Incidence rate ratio for incidence of receiving any own mother's milk at discharge in evaluation phase compared to pre-implementation phase

  Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)

• Receiving any own mother's milk on day 14 of life

  Incidence rate ratio for incidence of receiving any own mother's milk on day 14 of life in evaluation phase compared to pre-implementation phase

  Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)

• Severe NEC requiring surgery or resulting in death

  Incidence rate ratio for incidence of severe NEC requiring surgery or resulting in death in evaluation phase compared to pre-implementation phase

  Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)

Secondary Outcomes (2)

• Exclusive own mother's milk feeding at discharge

  Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)

• Any NEC, including NEC not requiring surgery and not resulting in death

  Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)

Study Arms (1)

Intervention group

Infants admitted to the 11 EMNODN neonatal units

Behavioral: EMNODN NEC Care Bundle

Interventions

EMNODN NEC Care Bundle BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include all infants born at \<32 weeks gestational age who are admitted to a neonatal unit in England and Wales which contributes data to the National Neonatal Research Database (NNRD).

You may qualify if:

• All infants born at \<32 weeks' gestational age admitted for neonatal care in England and Wales between 01/01/2016 to 30/09/2023 and who survived at least 48 hours

You may not qualify if:

• Infants whose data are not included in the National Neonatal Research Database (NNRD)

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• University of Nottingham: collaborator

Study Sites (1)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

Related Publications (1)

• Abramson J, Szatkowski L, Bains M, Orton E, Budge H, Spruce M, Ojha S. 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. BMJ Open. 2024 May 30;14(5):e078633. doi: 10.1136/bmjopen-2023-078633.

  PMID: 38816042 DERIVED

Related Links

• Description of EMNODN Care Bundle

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Breast Feeding

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Feeding Behavior; Behavior

Study Officials

• Shalini Ojha, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: July 6, 2023
• Study Start: December 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: May 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)