Monitoring Neonatal Resuscitation Trial (MONITOR)

University of Pennsylvania

Status: Completed

Conditions: Neonatal Prematurity; Positive-Pressure Respiration; Resuscitation

Treatments: Device: New Life Box Respiratory Function Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03256578

826695

NTR4104 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 patients

Sex: All

Ages: 24 to 28 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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288 participants in 2 patient groups

RFM visible

Experimental group

Description:

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.

Treatment:

Device: New Life Box Respiratory Function Monitor

RFM masked

No Intervention group

Description:

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.