Monitoring Neonatal Resuscitation Trial

Resuscitation Clinical Trial

— MONITOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256578
• Other study ID #: 826695
• Secondary ID: NTR4104
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: September 20, 2021

Study information

• Verified date: November 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: September 20, 2021
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 28 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Prematurity
• Positive-Pressure Respiration
• Premature Birth
• Resuscitation

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
University of Pennsylvania	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

Country where clinical trial is conducted

United States, 

References & Publications (2)

Schmölzer 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg	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.	the first 15 minutes of resuscitation
Secondary	Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life	Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life	approximately first 5 minutes of life
Secondary	Heart Rate in the First 10 Minutes of Life	Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life	between 3 and 10 minutes of life
Secondary	Percentage of Time With Mask Leak During PPV Ventilation	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.	approximately first 15 minutes of resuscitation
Secondary	Percentage of PPV Inflations With Airway Obstruction	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.	approximately first 15 minutes of resuscitation
Secondary	Percentage of PPV Inflations With Inadequate Tidal Volume	Percentage of PPV inflations with inadequate tidal volume defined as Vte <4 ml/kg in the first 15 minutes of resuscitation.	approximately first 15 minutes of resuscitation
Secondary	Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life	Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life	Between 3 and 10 minutes of life
Secondary	Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life	Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life	between 3 and 10 minutes of life
Secondary	Total Duration With FiO2 of 100% Delivered in the 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.	approximately first 10 minutes of life
Secondary	Number of Participants Receiving Endotracheal Intubation in the Delivery Room	Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU	from time of birth to admission to NICU
Secondary	Number of Participants Requiring Inotropes for Circulatory Support	Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth	within the first 3 days after birth
Secondary	Number of Participants With Pneumothorax	Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention	in the first 72 hours after birth
Secondary	Number of Participants With Pulmonary Interstitial Emphysema	Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention	in the first 72 hours of life
Secondary	Number of Participants With Abnormal Cranial Ultrasound Findings	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	through study completion, an average of 4 months
Secondary	Duration of Endotracheal Ventilation	Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months	days through study completion, an average of 4 months
Secondary	Duration of Non-invasive Ventilation	Duration of non-invasive ventilation, days through study completion, an average of 4 months	days through study completion, an average of 4 months
Secondary	Duration of Supplemental Oxygen Therapy	Duration of supplemental oxygen therapy days through study completion, an average of 4 months	days through study completion, an average of 4 months
Secondary	Total Duration of Assisted Ventilation	Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months	through study completion, an average of 4 months
Secondary	Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia	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	at 36 weeks corrected gestational age
Secondary	Neonatal Mortality	Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first	from time of birth until discharge from hospital, up to 44 weeks corrected gestational age
Secondary	Composite Outcome of Death or BPD	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	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
Secondary	Number of Participants With Retinopathy of Prematurity Requiring Treatment	Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months	before hospital discharge, an average of 4 months
Secondary	Number of Participants With a Diagnosis of Necrotizing Enterocolitis	Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months	before hospital discharge, an average of 4 months
Secondary	Number of Participants Requiring Fluid Boluses for Circulatory Support	Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life	within the first 3 days of life
Secondary	Number of Participants With Endotracheal Intubation in the NICU	Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life	in the first 24 hours of life
Secondary	Neonatal Mortality in the Delivery Room	Neonatal Mortality in the delivery room from time of birth until transfer to NICU	from time of birth until transfer to NICU