Monitoring clinical stability in extremely low birth weight infants after extubation
Official title: Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06037083 · Data updated 2026-11-12
This study is trying out a new monitoring system to see if it can help doctors better track the health of extremely low birth weight infants after they are taken off breathing machines.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 28 Weeks |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Status | Recruiting |
| Started | October 29, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | April 2027 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT06037083 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants with a birth weight less than 1000g and a gestational age of less than 28 weeks who have received mechanical ventilation within the first 72 hours of life.
✕Probably not a fit
Patients with congenital anomalies or congenital heart disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the feasibility of a multimodal monitoring system for extremely low birth weight infants at high risk of reintubation. It integrates clinical data and high-resolution waveforms from bedside monitors, along with regional oxygenation and ventilation measurements. The study will longitudinally assess oxygen saturation and ventilation in these infants during the week following extubation, aiming to improve the accuracy and standardization of clinical stability assessments. By providing a comprehensive view of organ function, the study seeks to inform reintubation decisions and tailor treatment plans.
Why it matters
Potential benefit: If successful, this approach could lead to better outcomes for extremely low birth weight infants by reducing the need for reintubation and improving individualized care.
How similar studies have gone: While this approach is innovative, similar multimodal monitoring strategies have shown promise in other populations, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Birth weight \< 1000g and gestational age \< 28+0 weeks, * Received mechanical ventilation within the first 72h of life, * Undergoing their first planned extubation within the first 6 weeks of life. Exclusion Criteria: \- Congenital anomalies and congenital heart disorders.
Where it's running
-
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada Recruiting -
McGill University Health Center
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Wissam Shalish, MD, PhD — McGill University Health Center/Montreal Children's hospital
- Study coordinator: Wissam Shalish, MD, PhD
- Email: wissam.shalish@mcgill.ca
- Phone: +1(514) 4124452
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.