Post-Extubation Assessment of Clinical Stability in ELBW Infants

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 28
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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).

  • 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).

  • 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)

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: 20 extremely low birth weight infants3 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

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

Time frame
168 hours
2

Consent rate

To evaluate the percentage of eligible infants consented

Time frame
168 hours
3

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.

Time frame
168 hours

Secondary outcomes

1

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

The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation, and compared between infants requiring reintubation and those not requiring reintubation during the 7 days after extubation.

Time frame
168 hours
2

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

The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation, and compared between infants requiring reintubation and those not requiring reintubation during the 7 days after extubation.

Time frame
168 hours
3

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

The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation. Repeated measures one-way ANOVA or Friedman test will be used to evaluate for differences in the variables over time.

Time frame
168 hours
4

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

The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation. Repeated measures one-way ANOVA or Friedman test will be used to evaluate for differences in the variables over time.

Time frame
96 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.