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Completed

NCT Number: NCT03256578

Monitoring Neonatal Resuscitation Trial

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.

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Key information

Age range

24 week–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

New Life Box Respiratory Function Monitor

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Karolinska University Hospital
  • Leiden University Medical Center
  • Maternal & Children's University Hospital, Valencia, Spain
  • Royal Women's Hospital in Melbourne, Australia
  • Vittore Buzzi Children's Hospital

Registry information

Official study title

A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth

Acronym: MONITOR

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Aug 22, 2017
Registry last updated
Nov 22, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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