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Monitoring Neonatal Resuscitation Trial (MONITOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03256578
Recruitment Status : Completed
First Posted : August 22, 2017
Results First Posted : January 19, 2021
Last Update Posted : November 22, 2021
Sponsor:
Collaborators:
Leiden University Medical Center
Royal Women's Hospital in Melbourne, Australia
Maternal & Children's University Hospital, Valencia, Spain
Vittore Buzzi Children's Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Elizabeth Foglia, University of Pennsylvania

Brief Summary:
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.

Condition or disease Intervention/treatment Phase
Resuscitation Neonatal Prematurity Positive-Pressure Respiration Device: New Life Box Respiratory Function Monitor Not Applicable

Detailed Description:

Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New Life Box uses a small variable orifice anemometer to measure gas flow in and out of a face-mask or endotracheal tube. This signal is automatically integrated to provide inspired (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from the infant is seen during a positive pressure inflation. The RFM can also calculate and measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all ventilation pressures. Using customized software heart rate, oxygen saturation and expired carbon dioxide can be integrated into the RFM.

The NewLife Box monitor presents graphical information for pressure, flow, and volume. In addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti, Vte), flow, respiratory rate and percent leak. The monitor integrates and displays physiologic data streaming from the patient (heart rate and oxygen saturation) as well as FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled, the monitor can incorporate video captured from an external camera. The video serves as a helpful aid in the interpretation of the events during the RFM waveform recordings.

The use of an RFM in the DR has the potential to improve neonatal respiratory support and reduce lung injury.

The primary objective of this study is to test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible infants are either randomized to the intervention, where the clinical team will be able to directly observe the monitor or randomized to the RFM-masked display arm, where they will only see a black screen.
Masking: Single (Outcomes Assessor)
Masking Description: The waveform data and videos captured during the study intervention will be centralized to Leiden University Medical Center. The team at Leiden University Medical Center assessing the outcomes will be will be blinded to the randomization allocation of the infant.
Primary Purpose: Health Services Research
Official Title: A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : May 17, 2019
Actual Study Completion Date : September 20, 2021

Arm Intervention/treatment
Experimental: RFM visible
During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.
Device: New Life Box Respiratory Function Monitor
The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.

No Intervention: RFM masked
During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.



Primary Outcome Measures :
  1. Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg [ Time Frame: the first 15 minutes of resuscitation ]
    To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.


Secondary Outcome Measures :
  1. Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life [ Time Frame: approximately first 5 minutes of life ]
    Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life

  2. Heart Rate in the First 10 Minutes of Life [ Time Frame: between 3 and 10 minutes of life ]
    Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life

  3. Percentage of Time With Mask Leak During PPV Ventilation [ Time Frame: approximately first 15 minutes of resuscitation ]
    Percentage of time with significant mask leak (defined as > 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.

  4. Percentage of PPV Inflations With Airway Obstruction [ Time Frame: approximately first 15 minutes of resuscitation ]
    Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte <1 mL/kg, with minimal mask leak (<25%) during an inflation and flattening of the flow waves.

  5. Percentage of PPV Inflations With Inadequate Tidal Volume [ Time Frame: approximately first 15 minutes of resuscitation ]
    Percentage of PPV inflations with inadequate tidal volume defined as Vte <4 ml/kg in the first 15 minutes of resuscitation.

  6. Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life [ Time Frame: Between 3 and 10 minutes of life ]
    Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life

  7. Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life [ Time Frame: between 3 and 10 minutes of life ]
    Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life

  8. Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life [ Time Frame: approximately first 10 minutes of life ]
    Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.

  9. Number of Participants Receiving Endotracheal Intubation in the Delivery Room [ Time Frame: from time of birth to admission to NICU ]
    Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU

  10. Number of Participants Requiring Inotropes for Circulatory Support [ Time Frame: within the first 3 days after birth ]
    Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth

  11. Number of Participants With Pneumothorax [ Time Frame: in the first 72 hours after birth ]
    Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention

  12. Number of Participants With Pulmonary Interstitial Emphysema [ Time Frame: in the first 72 hours of life ]
    Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention

  13. Number of Participants With Abnormal Cranial Ultrasound Findings [ Time Frame: through study completion, an average of 4 months ]
    Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months

  14. Duration of Endotracheal Ventilation [ Time Frame: days through study completion, an average of 4 months ]
    Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months

  15. Duration of Non-invasive Ventilation [ Time Frame: days through study completion, an average of 4 months ]
    Duration of non-invasive ventilation, days through study completion, an average of 4 months

  16. Duration of Supplemental Oxygen Therapy [ Time Frame: days through study completion, an average of 4 months ]
    Duration of supplemental oxygen therapy days through study completion, an average of 4 months

  17. Total Duration of Assisted Ventilation [ Time Frame: through study completion, an average of 4 months ]
    Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months

  18. Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia [ Time Frame: at 36 weeks corrected gestational age ]
    Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support

  19. Neonatal Mortality [ Time Frame: from time of birth until discharge from hospital, up to 44 weeks corrected gestational age ]
    Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first

  20. Composite Outcome of Death or BPD [ Time Frame: BPD assessed at corrected gestational age of 36 weeks; death assessed from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first ]
    Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age

  21. Number of Participants With Retinopathy of Prematurity Requiring Treatment [ Time Frame: before hospital discharge, an average of 4 months ]
    Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months

  22. Number of Participants With a Diagnosis of Necrotizing Enterocolitis [ Time Frame: before hospital discharge, an average of 4 months ]
    Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months

  23. Number of Participants Requiring Fluid Boluses for Circulatory Support [ Time Frame: within the first 3 days of life ]
    Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life

  24. Number of Participants With Endotracheal Intubation in the NICU [ Time Frame: in the first 24 hours of life ]
    Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life

  25. Neonatal Mortality in the Delivery Room [ Time Frame: from time of birth until transfer to NICU ]
    Neonatal Mortality in the delivery room from time of birth until transfer to NICU



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Ages Eligible for Study:   24 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
  • Receive positive pressure ventilation during delivery room resuscitation

Exclusion Criteria:

  • Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
  • RFM not available during resuscitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256578


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Leiden University Medical Center
Royal Women's Hospital in Melbourne, Australia
Maternal & Children's University Hospital, Valencia, Spain
Vittore Buzzi Children's Hospital
Karolinska University Hospital
Investigators
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Principal Investigator: Arjan te Pas, MD Leiden University Medical Center
  Study Documents (Full-Text)

Documents provided by Elizabeth Foglia, University of Pennsylvania:
Informed Consent Form  [PDF] February 14, 2019

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Foglia, Assistant Professor of Pediatrics, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03256578    
Other Study ID Numbers: 826695
NTR4104 ( Registry Identifier: Netherlands Trial Registry )
First Posted: August 22, 2017    Key Record Dates
Results First Posted: January 19, 2021
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elizabeth Foglia, University of Pennsylvania:
Resuscitation
Neonatal Prematurity
Positive-Pressure Ventilation
Respiratory Function Monitor
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications