Monitoring Neonatal Resuscitation Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2018 |
| Start Date: | February 20, 2017 |
| End Date: | August 20, 2020 |
| Contact: | Elizabeth Foglia, MD |
| Email: | foglia@email.chop.edu |
| Phone: | 215-662-3228 |
A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth
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.
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.
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.
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.
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
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Phone: 215-662-3228
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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