Necrotising Enterocolitis NeonatalNeoLapNCT07754435
Neonatal Laparotomy - A Trial Investigating the Impact of Location of Surgery
A study testing IN theatre and ON unit in people with Necrotising Enterocolitis Neonatal, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
This is a pilot randomised trial allocating neonates requiring emergency laparotomy to surgery either on the neonatal unit or in the operating theatre. Outcome will include physiological markers of instability, wound infection, death and others. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotising Enterocolitis Neonatal
- What is being tested?
- IN theatre and ON unit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Neonate requiring emergency surgery to the abdomen
- Parental consent given
- Clinician agreement for randomisation
Who cannot join
- Absolute indication for surgery in particular location
- No consent given
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neonatal Laparotomy - A Pilot Randomised Controlled Trial Investigating The Impact of Location of Surgery on Clinical Outcomes and Exploring the Implications For Neonatal, Anaesthetic and Surgical Service Provision
This is a pilot randomised trial allocating neonates requiring emergency laparotomy to surgery either on the neonatal unit or in the operating theatre.
Outcome will include physiological markers of instability, wound infection, death and others. There will also be a concurrent qualitative workstream exploring the impact of different practices on the wider clinical environment.
- Conditions
- Necrotising Enterocolitis Neonatal
- Being tested
- IN theatre, ON unit
- Keywords
- Neonatal, Surgery
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN theatreProcedure or surgery
Surgery will take place in the operating theatre
ON unitProcedure or surgery
Surgery will take place on the neonatal unit
| Study group | Role | What they receive |
|---|---|---|
| In unit surgery | Active comparator | Babies will have their surgery performed on the neonatal unit without transfer to a theatre Receives: Procedure: ON unit |
| Theatre operating | Active comparator | Babies will be transferred to the operating theatre for surgery Receives: Procedure: IN theatre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Survival to discharge
Measured: Until discharge from hospital from primary episode, around 3-4 months
Secondary outcomes (1)
Physiological parameters
As a pilot study, many different physiological parameters as markers of clinical stability will be collected and assessed for their suitability in a definitive study
Measured: During the course of the admission, including the immediate peri-operative period and subsequent recovery phase. Four weeks from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotising Enterocolitis NeonatalStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754435
- Sponsor's protocol ID
- 358533
- Other IDs
- X240202
- Acronym
- NeoLap
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Laparotomy - A Pilot Randomised Controlled Trial Investigating The Impact of Location of Surgery on Clinical Outcomes and Exploring the Implications For Neonatal, Anaesthetic and Surgical Service Provision
- ClinicalTrials.gov ID
- NCT07754435
- Acronym / sponsor ID
- NeoLap / 358533
- Conditions
- Necrotising Enterocolitis Neonatal
- Keywords
- Neonatal, Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Aug 2026 (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.
This is a pilot randomised trial allocating neonates requiring emergency laparotomy to surgery either on the neonatal unit or in the operating theatre.
Outcome will include physiological markers of instability, wound infection, death and others. There will also be a concurrent qualitative workstream exploring the impact of different practices on the wider clinical environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In unit surgery | Active comparator | Procedure: ON unitBabies will have their surgery performed on the neonatal unit without transfer to a theatre |
| Theatre operating | Active comparator | Procedure: IN theatreBabies will be transferred to the operating theatre for surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Neonate requiring emergency surgery to the abdomen
- Parental consent given
- Clinician agreement for randomisation
Key exclusion criteria (2 listed)
- Absolute indication for surgery in particular location
- No consent given
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 |
|---|---|---|
| IN theatreSurgery will take place in the operating theatre | Procedure or surgery | Theatre operating |
| ON unitSurgery will take place on the neonatal unit | Procedure or surgery | In unit surgery |
Primary outcome
Death
Time frame: Until discharge from hospital from primary episode, around 3-4 months
Survival to discharge
1 secondary outcome
Physiological parameters
Time frame: During the course of the admission, including the immediate peri-operative period and subsequent recovery phase. Four weeks from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing IN theatre and ON unit in people with Necrotising Enterocolitis Neonatal, run by Guy's and St Thomas' NHS Foundation Trust.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iain E Yardley, FRCS BM MPH (00447901777079, i.yardley@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Until discharge from hospital from primary episode, around 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.