New care bundle aims to slash deadly gut disease in preterm babies
NCT ID NCT05934123
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study looks at whether a set of guidelines called the EMNODN NEC Care Bundle helps very preterm babies (born before 32 weeks) get more of their own mother's milk and reduces a life-threatening gut condition called necrotising enterocolitis (NEC). Researchers will compare data from over 53,000 babies born in England and Wales before and after the bundle was introduced. The goal is to see if the bundle works and which parts are most helpful.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EMNODN NEC Care Bundle (a set of guidelines and support practices for neonatal units)
- What this could lead to
- If effective, this care bundle could help more preterm babies receive their mother's milk and lower the risk of a life-threatening gut disease called NEC.
- What could go wrong
- This is an observational study comparing before-and-after data, not a randomized trial, so other factors could explain any changes. The bundle may not work equally well in all hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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53,600 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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).
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion criteria: * Infants whose data are not included in the National Neonatal Research Database (NNRD)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University Hospitals of Derby and Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3DT, United Kingdom
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