Operating theatre or bedside? trial tests best setting for newborn emergency surgery
NCT ID NCT07754435
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This pilot trial is asking whether emergency abdominal surgery for newborns with a serious gut condition called necrotising enterocolitis should be done in the operating theatre or right on the neonatal unit. It will compare outcomes like stability during surgery, wound infections, and survival to discharge. The study also looks at how each setting affects the wider clinical environment. With only 15 participants, this is an early step to see if a larger trial is feasible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Location of surgery (operating theatre vs. neonatal unit)
- What this could lead to
- If successful, this could guide where emergency neonatal abdominal surgeries are best performed to improve outcomes and inform service planning.
- What could go wrong
- This is a small pilot study, so results may not be definitive. The two locations may show no clear difference, and logistical or clinical factors could limit generalizability.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- 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.
- 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: * Neonate requiring emergency surgery to the abdomen * Parental consent given * Clinician agreement for randomisation Exclusion Criteria: * Absolute indication for surgery in particular location * No consent given
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.