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Completed

NCT Number: NCT01909947

Prediction of Extubation Readiness in Extreme Preterm Infants by the Automated Analysis of CardioRespiratory Behavior

The investigators hypothesize that machine learning methods using a combination of novel, quantitative measures of cardio-respiratory variability can accurately predict the optimal time to extubate extreme preterm infants. In this multicenter prospective study, cardiorespiratory signals will be recorded from 250 extreme preterm infants who are eligible for extubation. Automated signal analysis algorithms will compute a variety of metrics for each infant describing the cardiorespiratory state. Machine learning methods will then be used to find the optimal combination of these statistical measures and clinical features that provide the best overall predictor of extubation readiness. Finally, investigators will develop an Automated system for Prediction of EXtubation (APEX) that will integrate the software for data acquisition, signal analysis, and outcome prediction into a single application suitable for use by medical personnel in the Neonatal Intensive Care Unit (NICU). The performance of APEX will later be clinically validated in 50 additional infants prospectively.

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Key information

Conditions

Prediction of Extubation Readiness

Sex eligibility

All sexes

Study type

Observational

Primary location

Jewish General Hospital, Montreal, Quebec, Canada

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About this study

At birth, extreme preterm infants (≤28 weeks) have inconsistent respiratory drive, airway instability, surfactant deficiency and immature lungs that frequently result in respiratory failure. Management of these infants is difficult and most will require endotracheal intubation and mechanical ventilation (ETT-MV) within the first days of life to survive. ETT-MV is an invasive therapy that is associated with adverse clinical outcomes including ventilator-associated pneumonia, impaired neurodevelopment, and increased mortality. Consequently, clinicians try to remove ETT-MV as quickly as possible. However, 25 to 35% of these extubation attempts will fail and infants will require reintubation, an intervention that is also associated with increased morbidity and mortality. Therefore physicians must determine the optimal time for extubation which minimizes the duration of ETT-MV and maximizes the chances of success. A variety of objective measures have been proposed to assist with this decision but none has proven to be useful clinically. Investigators from this group have recently explored the predictive power of indices of autonomic nervous system function based on measurements of heart rate (HRV) and respiratory variability (RV). The use of sophisticated, automated algorithms to analyze those cardiorespiratory signals have shown some promising preliminary results in predicting which infants can be extubated successfully.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All infants admitted to the NICU with a birth weight ≤ 1250 grams AND
  • Need for endotracheal tube mechanical ventilation

Exclusion criteria

  • Infants with major congenital anomalies
  • Infants with congenital heart disease and cardiac arrhythmias
  • Infants receiving vasopressor or sedative drugs at the time of extubation
  • Infants extubated directly from high frequency ventilation
  • Infants extubated to room air, oxyhood or low-flow nasal cannula

Treatment and study plan

Cardiorespiratory signal acquisition

Other

Cardiorespiratory signals will measure heart rate (using electrocardiography), chest and abdominal movements (using respiratory inductance plethysmography) and oxygen saturation (using pulse oximetry). Data will be acquired during 2 recording periods:

  • A 60-minute period while the infant receives any mode of conventional mechanical ventilation
  • A 5-minute period prior to extubation while the mode of ventilation is switched to endotracheal tube CPAP (Continuous Positive Airway Pressure), so that the respiratory pattern will be controlled by the infant

Primary outcomes

  1. Extubation Failure

    Time frame: Within 72 hours of extubation

    Infants will be considered to have failed extubation if they meet one or more of the following criteria within 72 hours of extubation:

    • Fraction of inspired oxygen (FiO2) > 0.5 in order to maintain oxygen saturation (SpO2) > 88% or PaO2 > 45 mmHg (for 2 consecutive hours)
    • PaCO2 > 55-60 mmHg with a pH < 7.25 in two consecutive blood gases done 1-2 hours apart
    • 1 episode of apnea requiring positive pressure ventilation with bag and mask
    • Multiple episodes of apnea (≥ 6 episodes / 6 hours).

Secondary outcomes

  1. The need for reintubation within 72h of the first planned extubation

    Time frame: Within 72 hours of extubation

    The decision to re-intubate will be made by the responsible physician, who may not always follow the guidelines stated in the primary objective. Therefore, reintubation will be assessed as a secondary outcome.

  2. The need for reintubation

    Time frame: Anytime from the first planned extubation until discharge from the neonatal intensive care unit

    Infants will be prospectively followed from birth until discharge from the NICU. Therefore, infants who require reintubation at any time point from the first planned extubation until discharge from the neonatal intensive care unit will be documented

Other outcomes

  1. Total duration of ETT-MV

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

    Total duration (in days) of endotracheal tube mechanical ventilation from the time of birth until discharge from the hospital

  2. Intraventricular hemorrhage

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

    Presence of Intraventricular Hemorrhage (IVH) from time of birth until discharge from the hospital. If IVH is present, the grade of the hemorrhage will be specified (as per Volpe's classification)

  3. Patent Ductus Arteriosus

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

    Presence of a Patent Ductus Arteriosus (PDA) from the time of birth until discharge from hospital. If present, the therapeutic measures taken for closing the PDA (medical or surgical) will also be specified.

  4. Oxygen supplementation at 28 days of life

    Time frame: This outcome will be assessed when participants have 28 days of life

    The need for any oxygen supplementation at 28 days of life

  5. Bronchopulmonary Dysplasia

    Time frame: This outcome will be assessed when participants are 36 weeks post-conceptual age

    The presence of Bronchopulmonary Dysplasia (BPD) will be assessed at 36 weeks Post Conceptual Age (PCA) and classified as mild, moderate or severe.

    • Mild BPD: oxygen supplementation at 28 days of life but none at 36 weeks PCA
    • Moderate BPD: FiO2 requirements of less than 0.3 at 36 weeks PCA
    • Severe BPD: FiO2 requirements over 0.3 or CPAP or mechanical ventilation at 36 weeks PCA

  6. Retinopathy of Prematurity

    Time frame: This outcome will be assessed at the time of the first eye exam (approximately 31 weeks PCA) until the final eye exam prior to hospital discharge

    Participants will be assessed for the presence or absence of Retinopathy of Prematurity (ROP)

  7. Necrotizing Enterocolitis

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

    Participants will be assessed for the presence or absence of Necrotizing Enterocolitis (NEC) throughout the course of their hospitalization. NEC will be classified according to Bell's modified staging criteria.

  8. Death

    Time frame: Participants will be followed for the duration of hospital stay in the NICU, an expected average of 10 weeks

    Death occuring anytime during the hospitalization course in the NICU.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Brown University
  • Canadian Institutes of Health Research (CIHR)
  • Wayne State University

Registry information

Official study title

Prediction of Extubation Readiness in Extreme Preterm Infants by the Automated Analysis of CardioRespiratory Behavior: the APEX Study

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2013
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.