Clinical trial NCT06037083: Post-Extubation Assessment of Clinical Stability in ELBW Infants
Official title: Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: the PEACE Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extremely Low Birth Weight Infants
Keywords: Reintubation
Extubation
Extremely low birth weight infants
Electrical impedance tomography
Cerebral and splanchnic oxygenation
Near infrared spectroscopy
apnea
intermittent hypoxia
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: St. Justine's Hospital
First posted: 2023-09-14
Enrollment: 20
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 extremely low birth weight preterm infants admitted to the neonatal intensive care unit at the Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine.

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.

Detailed description: The primary aim of this proof-of-concept study is to evaluate the feasibility and acceptance of a monitoring system that integrates clinical data and biomedical signals from multiple modalities in a cohort of extremely preterm infants at high-risk of clinical instability on non-invasive respiratory support.

Secondary aims will be to longitudinally describe peripheral oxygen saturation, cerebral oxygen saturation, splanchnic oxygen saturation and regional lung ventilation in extremely low birth weight infants with or without reintubation during the 7 days post extubation.

The application of this multimodal monitoring approach using both clinical and physiological data during the postextubation period will help by making the assessment of clinical stability more comprehensive, more objective, more accurate, more standardized, and more reflective of important end-organ function. Thus, the proposed multimodal monitoring could lead to more informed decisions about reintubation and more individualized treatment plans during this critical period, hence potentially leading to better outcomes.

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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 168 hours
measure: Consent rate
timeFrame: 168 hours
measure: Acceptability of the multimodal monitoring approach
timeFrame: 168 hours
Secondary outcomes:
measure: To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
timeFrame: 168 hours
measure: To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
timeFrame: 168 hours
measure: To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
timeFrame: 168 hours
measure: To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation.
timeFrame: 96 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
Study officials:
affiliation: McGill University Health Center/Montreal Children's hospital
name: Wissam Shalish, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: