NCT07754435

Brief 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. There will also be a concurrent qualitative workstream exploring the impact of different practices on the wider clinical environment.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

July 16, 2026

Last Update Submit

August 4, 2026

Conditions

Necrotising Enterocolitis Neonatal

Keywords

NeonatalSurgery

Outcome Measures

Primary Outcomes (1)

  • Death

    Survival to discharge

    Until discharge from hospital from primary episode, around 3-4 months

Secondary Outcomes (1)

  • Physiological parameters

    During the course of the admission, including the immediate peri-operative period and subsequent recovery phase. Four weeks from surgery

Study Arms (2)

In unit surgery

ACTIVE COMPARATOR

Babies will have their surgery performed on the neonatal unit without transfer to a theatre

Procedure: ON unit

Theatre operating

ACTIVE COMPARATOR

Babies will be transferred to the operating theatre for surgery

Procedure: IN theatre

Interventions

IN theatrePROCEDURE

Surgery will take place in the operating theatre

Theatre operating
ON unitPROCEDURE

Surgery will take place on the neonatal unit

In unit surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Neonate requiring emergency surgery to the abdomen
  • Parental consent given
  • Clinician agreement for randomisation

You may not qualify if:

  • Absolute indication for surgery in particular location
  • No consent given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Iain E Yardley, FRCS BM MPH

CONTACT

00447901777079i.yardley@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2026

First Posted

August 10, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share