Oral and Gastrointestinal Digestive System
Conditions
Interventions
GASTRIC-PICU is a multi-centre, randomised, noninferiority, open-label trial with an internal pilot phase (with clear stop/go progression criteria to full trial) and health economic evaluation and pat
Sponsors
Intensive Care National Audit & Research Centre
Eligibility
Sex/Gender
All
Age
37 Weeks to 16 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 20/05/2024: 1. Aged > = 37 weeks corrected gestational age and = 37 weeks corrected gestational age and < 16 years at the time of randomisation 2. Receiving invasive mechanical ventilation (with extubation not planned in the next 48 hours) 3. Intention to start feeding via the gastric route (including gastrostomy)
Exclusion criteria
Exclusion criteria: 1. Post-pyloric feeding or jejunostomy 2. End-of-life care plan in place with limitation of resuscitation 3. Children on long-term mechanical ventilation 4. Current or recent gut pathology or surgery (e.g., necrotising enterocolitis (NEC), active GI bleeding, or any intestinal surgery) 5. Known to have been enrolled in the GASTRIC-PICU trial in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Composite outcome of survival and days free from mechanical ventilation measured using patient medical records at 30 days (non-inferiority) 2. Percentage of the child’s estimated energy requirements achieved by 72 hours after randomisation (superiority) measured using patient medical records and Schofield equation at 72 hours post-randomisation 3. Incremental net monetary benefits at six months (cost-effectiveness analysis) measured using health care services questionnaire and patient medical notes at 6 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to the achievement of target energy requirement measured using patient medical records and Schofield equation at 72 hours post-randomisation 2. Time to the achievement of target protein requirement measured using patient medical records at 72 hours post-randomisation 3. Diagnosis of ventilator-associated pneumonia (VAP) measured using patient medical records at 30 days post-randomisation 4. Diagnosis of necrotising enterocolitis (NEC) in infants – using patient medical records at 30 days post-randomisation 5. Duration of time with no enteral feed in the first 7 days after randomisation measured using patient medical records at 7 days 6. Incidence of vomiting leading to feed stoppage in the first 7 days after randomisation measured using patient medical records at 7 days 7. Documented healthcare-acquired infections measured using patient medical records at 30 days post-randomisation 8. Length of PICU stay and hospital stay measured using patient medical records at 30 days and 6 months post-randomisation 9. Mortality at 30 days and 6 months measured using patient medical records at 30 days and 6 months post-randomisation 10. Resource use and costs measured using Health Care services questionnaires at 6 months 11. Health-related quality of life measured using the pediatric quality of life inventory (PedsQL) and the validity of the child health utility instrument (CHU9D) questionnaire data at 6 months post-randomisation 12. Quality-adjusted life years (QALYs) measured using PedsQL and CHU-9D questionnaire data at 6 months post-randomisation 13. Feeding measured using the feeding component of the Functional Status Score at 6 months post-randomisation | — |
Countries
England, Northern Ireland, Scotland, Switzerland, United Kingdom, Wales
Contacts
Public ContactGASTRIC-PICU Team
Outcome results
None listed