RecruitingNot Applicable

Post-Extubation Assessment of Clinical Stability in ELBW Infants

Canada20 participantsStarted 2024-10-29

Plain-language 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.

Who can participate

Age range28 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Recruitment rate

Timeframe: 168 hours

Consent rate

Timeframe: 168 hours

Acceptability of the multimodal monitoring approach

Timeframe: 168 hours

Trial details

NCT IDNCT06037083

SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Wissam Shalish, MD, PhD

+1(514) 4124452 wissam.shalish@mcgill.ca

View on ClinicalTrials.gov More Extremely Low Birth Weight Infants trials