Post-Extubation Assessment of Clinical Stability in ELBW Infants

NCT06037083 | Recruiting

• 1 other identifier: 2023-8794
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited

  168 hours

• Consent rate

  To evaluate the percentage of eligible infants consented

  168 hours

• Acceptability of the multimodal monitoring approach

  Acceptability of the multimodal monitoring approach will be evaluated using short anonymous surveys distributed to parents, bedside nurses, and attending clinicians participating in the study.

  168 hours

Secondary Outcomes (4)

• To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation

  168 hours

• To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation

  168 hours

• To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation

  168 hours

• To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation.

  96 hours

Study Arms (1)

20 extremely low birth weight infants

In addition to the standard care, all participants will be monitored using an extra oxygen saturation probe, two near infrared spectroscopy sensors, and an electrical impedance tomography belt. Data will be continuously collected from extubation to 168 hours postextubation

Device: Oxygen saturation probe; Device: Near infrared spectroscopy sensors; Device: Electrical impedance tomography

Interventions

Oxygen saturation probe DEVICE

The high-accuracy oxygen saturation signal will be continuously acquired for 168 hours post extubation from a separate pulse oximeter (Radical-7®, Masimo ROOT platform, MasimoCorp, Irvine, LA).

20 extremely low birth weight infants

Near infrared spectroscopy sensors DEVICE

The cerebral and splanchnic regional oxygen saturation signals will be acquired continuously for 168h post extubation using two near infrared spectroscopy sensors (Masimo ROOT platform, MasimoCorp, Irvine, LA), one placed on the forehead for cerebral oxygenation and one on the abdomen (for splanchnic oxygenation).

20 extremely low birth weight infants

Electrical impedance tomography DEVICE

The regional lung ventilation will be measured using Electrical Impedance Tomography (TIMPEL, USA) at three time points: * From 1 hour pre-extubation to 2 hours post extubation (total 3 hours) * Between 24 and 48 hours post extubation (total 3 hours) * Between 72 and 96 hours post extubation (total 3 hours)

20 extremely low birth weight infants

Eligibility Criteria

• Age: Up to 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Congenital anomalies and congenital heart disorders.

Sponsors & Collaborators

• St. Justine's Hospital: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (2)

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wissam Shalish, MD, PhD

  McGill University Health Center/Montreal Children's hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wissam Shalish, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, McGill University Neonatologist, Montreal Children's Hospital

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 14, 2023
• Study Start: October 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)