Necrotising Enterocolitis Neonatal
Conditions
Keywords
Neonatal, Surgery
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.
Interventions
PROCEDUREIN theatre
Surgery will take place in the operating theatre
PROCEDUREON unit
Surgery will take place on the neonatal unit
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | Until discharge from hospital from primary episode, around 3-4 months | Survival to discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological parameters | 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 |
Contacts
CONTACTIain E Yardley, FRCS BM MPH
Outcome results
None listed