Monitoring Neonatal Resuscitation Trial
Condition: Resuscitation; Neonatal Prematurity; Positive-Pressure Respiration
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Intervention name(s): New Life Box Respiratory Function Monitor
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Resuscitation; Neonatal Prematurity; Positive-Pressure Ventilation; Respiratory Function Monitor