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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Necrotising Enterocolitis Neonatal
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Infants 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.
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)
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)
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)
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)
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.
- First posted6 Jul 2023
- Study start1 Dec 2022
- Primary completion30 Sep 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotising Enterocolitis NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Shalini Ojha, PhD, Principal investigator, University of Nottingham
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05934123
- Acronym / sponsor ID
- EMNODN-NEC / UHDB/2021/059
- Conditions
- Necrotising Enterocolitis Neonatal
- Keywords
- Breastfeeding, Necrotising enterocolitis, Care bundle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53,600 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Behavioral: EMNODN NEC Care BundleInfants admitted to the 11 EMNODN neonatal units |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Infants whose data are not included in the National Neonatal Research Database (NNRD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMNODN NEC Care BundleA 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. | Behavioural | Intervention group |
Primary outcome
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)
Incidence rate ratio for incidence of receiving any own mother's milk at discharge in evaluation phase compared to pre-implementation phase
Receiving any own mother's milk on day 14 of life
Time frame: Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)
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
Severe NEC requiring surgery or resulting in death
Time frame: Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)
Incidence rate ratio for incidence of severe NEC requiring surgery or resulting in death in evaluation phase compared to pre-implementation phase
2 secondary outcomes
Exclusive own mother's milk feeding at discharge
Time frame: 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
Time frame: Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 38816042Abramson 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.
- Description of EMNODN Care BundleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Ojha, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
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.