AzTrials
AzTrials

Necrotising Enterocolitis NeonatalEMNODN-NECNCT05934123

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

An observational study of Necrotising Enterocolitis Neonatal, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Necrotising Enterocolitis Neonatal
What is being tested?
EMNODN NEC Care Bundle
How many people
53,600 participants
Where
1 siteUnited Kingdom
Study dates
1 Dec 2022to 31 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University Hospitals of Derby and Burton NHS Foundation Trust

    Derby, Derbyshire, DE22 3DT

Other trials in United Kingdom

About this study

Official title: Effects of Implementation of a Care Bundle on Rates of Necrotising Enterocolitis and Own Mother's Milk Feeding in the East Midlands: a Mixed Methods Impact and Process Evaluation Study

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.

Read more

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.

Read the detailed description

Necrotising enterocolitis (NEC) is a serious, life-threatening disease in preterm infants. Preterm birth, affecting over 52,000 babies per year (around 7.3% of live births), is the largest cause of neonatal mortality in the UK. The 2019 NHS Long Term Plan aims to reduce neonatal mortality by 50% with plans to "improve the safety and effectiveness of neonatal critical care" and "enhance the experiences of families" during this worrying period.

An estimated 12% of infants born weighing <1500g develop NEC and 30% of these die. Survivors have an increased risk of adverse neurodevelopmental outcomes, including cerebral palsy and cognitive impairment. In the UK, NEC rates are collected by the National Neonatal Audit Programme (NNAP), a national audit run by the Royal College of Paediatrics and Child Health, commissioned by the Healthcare Quality Improvement Partnership (https://nnap.rcpch.ac.uk).

The East Midlands Neonatal Operational Delivery Network (EMNODN) (https://www.emnodn.nhs.uk) is one of 11 clinically managed Neonatal Operational Delivery Networks in England. ODNs were formed, in 2003, by the Department of Health, to ensure that babies and their families receive high quality, equitable and accessible care. The rate of NEC in the EMNODN has remained above the national average since 2017 (when this measure was added to NNAP) and there are wide variations between units.

Preterm infants are unable to directly suckle on the breast. Mothers express breastmilk which is fed to their infant via an oro/nasogastric tube. As infants grow and mature, they develop the ability to suck and swallow and establish breastfeeding. Some infants continue to receive own mother's milk via a cup, syringe, or bottle as per parental choice; all these are included within 'own mother's milk feeding'. Encouraging and supporting own mother's milk feeding prevents NEC and has several additional advantages, including improved long-term neurodevelopment and parent-infant bonding. Health economic analysis estimates that if all premature infants were fed own mother's milk, the total lifetime cost saving to the NHS would be £46.7 million (£30.1 million in the first year of life) and there would be 238 fewer deaths per year with a gain of £153.4 million in lifetime productivity. The adjusted incremental costs of medical NEC and surgical NEC over and above the average costs incurred for extremely premature infants without NEC, in 2011, were estimated to be $74,004 (95% confidence interval (CI), $47,051-$100,957) and $198,040 (95% CI, $159,261-$236,819) per infant, respectively.

Early start and continuation of feeding with own mother's milk, such that babies go home breastfeeding, is vital to ensure babies continue to receive own mother's milk throughout neonatal care and remain at a reduced risk of NEC. Unfortunately, in NNAP, rates of any breast milk feeding at discharge in EMNODN have been consistently below the national average, again with wide local variations.

National recommendations cite a need for quality improvement (QI) efforts to boost own mother's milk feeding to reduce NEC. In 2020, NNAP recommended that "if rates of NEC are relatively high, seek to identify and implement potentially better practices" and to "focus on the early initiation and sustainment of breastmilk feeding in conjunction with parents by reviewing data and processes" and "undertake selected QI activities suited to the local context". In keeping with this, the EMNODN has created a NEC Care Bundle which was introduced it to the 11 neonatal units in September 2022, with use fully embedded by December 2022.

Care bundles are a group of evidence-based interventions related to a disease or care process that, when executed together, result in better outcomes than when implemented individually. Interventions should be evidence-based, accepted as best practice, simple to implement, and part of day-to-day practice. This care bundle consists of recommendations, and parent-facing information, created by a multi-disciplinary team. It contains recommendations in two main areas: promotion of own mother's milk feeding and optimising nutritional care of preterm infants by ensuring early and adequate parenteral nutrition, given when infants cannot have sufficient milk feeds such as in the first hours after birth, while building milk feeds and when unwell, oropharyngeal colostrum (practice of giving own mothers' first milk directly into the infant's oropharynx to enhance immunity and protect against NEC), optimal time and speed of increasing milk feeds, and use of other interventions such as human donor milk, probiotics and breast milk fortifiers.

There is some evidence that QI programmes using care bundles can improve rates of own mother's milk feeding in neonatal units. A study in the East of England showed that introduction of a care bundle increased the prevalence of own mother's milk feeding from 50 to 57%. While such previous studies have looked at some measures of effectiveness of implementation, none have explored the effect of complex interventions on NEC rates and other feeding practices.

Being tested
EMNODN NEC Care Bundle
Keywords
Breastfeeding, Necrotising enterocolitis, Care bundle
Medical subject headings
Enterocolitis, Necrotizing, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMNODN NEC Care BundleBehavioural

    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.

Study groups in NCT05934123
Study groupRoleWhat they receive
Intervention groupInfants admitted to the 11 EMNODN neonatal units
Receives: Behavioral: EMNODN NEC Care Bundle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

Secondary outcomes (2)
  1. Exclusive own mother's milk feeding at discharge

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

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

  2. Any NEC, including NEC not requiring surgery and not resulting in death

    Incidence rate ratio for incidence of any NEC in evaluation phase compared to pre-implementation phase

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start1 Dec 2022
  3. Primary completion30 Sep 2024
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
53,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934123
Sponsor's protocol ID
UHDB/2021/059
Acronym
EMNODN-NEC
Status last verified
Feb 2025
First submitted
23 Mar 2023
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38816042

Questions about this trial

What is this clinical trial studying?

An observational study of Necrotising Enterocolitis Neonatal, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Receiving any own mother's milk at discharge (time frame: Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05934123, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in