Clinical trial NCT03256578: Monitoring Neonatal Resuscitation Trial
Official title: A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resuscitation
Neonatal Prematurity
Positive-Pressure Respiration
Keywords: Resuscitation
Neonatal Prematurity
Positive-Pressure Ventilation
Respiratory Function Monitor
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Royal Women's Hospital in Melbourne, Australia
name: Maternal & Children's University Hospital, Valencia, Spain
name: Vittore Buzzi Children's Hospital
name: Karolinska University Hospital
First posted: 2017-08-22
Enrollment: 288
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg
timeFrame: the first 15 minutes of resuscitation
Secondary outcomes:
measure: Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life
timeFrame: approximately first 5 minutes of life
measure: Heart Rate in the First 10 Minutes of Life
timeFrame: between 3 and 10 minutes of life
measure: Percentage of Time With Mask Leak During PPV Ventilation
timeFrame: approximately first 15 minutes of resuscitation
measure: Percentage of PPV Inflations With Airway Obstruction
timeFrame: approximately first 15 minutes of resuscitation
measure: Percentage of PPV Inflations With Inadequate Tidal Volume
timeFrame: approximately first 15 minutes of resuscitation
measure: Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life
timeFrame: Between 3 and 10 minutes of life
measure: Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life
timeFrame: between 3 and 10 minutes of life
measure: Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life
timeFrame: approximately first 10 minutes of life
measure: Number of Participants Receiving Endotracheal Intubation in the Delivery Room
timeFrame: from time of birth to admission to NICU
measure: Number of Participants Requiring Inotropes for Circulatory Support
timeFrame: within the first 3 days after birth
measure: Number of Participants With Pneumothorax
timeFrame: in the first 72 hours after birth
measure: Number of Participants With Pulmonary Interstitial Emphysema
timeFrame: in the first 72 hours of life
measure: Number of Participants With Abnormal Cranial Ultrasound Findings
timeFrame: through study completion, an average of 4 months
measure: Duration of Endotracheal Ventilation
timeFrame: days through study completion, an average of 4 months
measure: Duration of Non-invasive Ventilation
timeFrame: days through study completion, an average of 4 months
measure: Duration of Supplemental Oxygen Therapy
timeFrame: days through study completion, an average of 4 months
measure: Total Duration of Assisted Ventilation
timeFrame: through study completion, an average of 4 months
measure: Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia
timeFrame: at 36 weeks corrected gestational age
measure: Neonatal Mortality
timeFrame: from time of birth until discharge from hospital, up to 44 weeks corrected gestational age
measure: Composite Outcome of Death or BPD
timeFrame: 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
measure: Number of Participants With Retinopathy of Prematurity Requiring Treatment
timeFrame: before hospital discharge, an average of 4 months
measure: Number of Participants With a Diagnosis of Necrotizing Enterocolitis
timeFrame: before hospital discharge, an average of 4 months
measure: Number of Participants Requiring Fluid Boluses for Circulatory Support
timeFrame: within the first 3 days of life
measure: Number of Participants With Endotracheal Intubation in the NICU
timeFrame: in the first 24 hours of life
measure: Neonatal Mortality in the Delivery Room
timeFrame: from time of birth until transfer to NICU
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Leiden University Medical Center
name: Arjan te Pas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wood FE, Morley CJ, Dawson JA, Davis PG. A respiratory function monitor improves mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2008 Sep;93(5):F380-1. doi: 10.1136/adc.2007.120097. Epub 2008 Jan 11.
citation: Schmolzer GM, Kamlin OC, Dawson JA, te Pas AB, Morley CJ, Davis PG. Respiratory monitoring of neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F295-303. doi: 10.1136/adc.2009.165878. Epub 2009 Sep 22.
citation: van Zanten HA, Kuypers KLAM, van Zwet EW, van Vonderen JJ, Kamlin COF, Springer L, Lista G, Cavigioli F, Vento M, Nunez-Ramiro A, Oberthuer A, Kribs A, Kuester H, Horn S, Weinberg DD, Foglia EE, Morley CJ, Davis PG, Te Pas AB. A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth. Resuscitation. 2021 Oct;167:317-325. doi: 10.1016/j.resuscitation.2021.07.012. Epub 2021 Jul 22.