Post-Extubation Assessment of Clinical Stability in ELBW Infants (PEACE)

McGill University

Status: Enrolling

Conditions: Extremely Low Birth Weight Infants

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

Study type: Observational

Funder types: Other

Identifiers

NCT06037083

2023-8794

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 28 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

20 extremely low birth weight infants

Description:

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

Treatment:

Device: Near infrared spectroscopy sensors

Device: Oxygen saturation probe

Device: Electrical impedance tomography