Neonatal Laparotomy - A Trial Investigating the Impact of Location of Surgery

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.

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Key information

Conditions

Necrotising Enterocolitis Neonatal Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IN theatre

Procedure

Surgery will take place in the operating theatre

ON unit

Procedure

Surgery will take place on the neonatal unit

Primary outcomes

Death

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

Survival to discharge

Secondary outcomes

Physiological parameters

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Iain E Yardley, FRCS BM MPH

CONTACT

[email protected]

00447901777079

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: NeoLap

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Aug 10, 2026
Registry last updated: Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by invitation