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
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.
- 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