NCT06037083 Post-Extubation Assessment of Clinical Stability in ELBW Infants
| NCT ID | NCT06037083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Extremely Low Birth Weight Infants |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-10-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared spectroscopy), and regional ventilation (via electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.
Eligibility 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.
Contact & Investigator
Wissam Shalish, MD, PhD
PRINCIPAL INVESTIGATOR
McGill University Health Center/Montreal Children's hospital
Frequently Asked Questions
Who can join the NCT06037083 clinical trial?
This trial is open to participants of all sexes, up to 28 Weeks, studying Extremely Low Birth Weight Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06037083 currently recruiting?
Yes, NCT06037083 is actively recruiting participants. Contact the research team at wissam.shalish@mcgill.ca for enrollment information.
Where is the NCT06037083 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06037083 clinical trial?
NCT06037083 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Wissam Shalish, MD, PhD at McGill University Health Center/Montreal Children's hospital. The trial plans to enroll 20 participants.