At a glance
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A Randomised Trial of Routine or Selective Application of a Face Mask for Preterm Infants at Birth
In Brief
A clinical study evaluating Face mask application for CPAP and/or PPV delivery for Infant, Premature, Diseases and 4 related conditions. Completed, enrolled 201 participants across 1 site.
Detailed Summary
International guidelines recommend giving positive pressure ventilation (PPV) by face mask to newborns who do not breathe or have a slow heart rate at birth. Preterm infants are at high risk of developing respiratory distress syndrome (RDS) and many are treated with continuous positive airway pressure (CPAP) in the neonatal intensive care unit (NICU). Though the majority of preterm infants breathe spontaneously at birth, many clinicians routinely apply a face mask to preterm infants shortly after birth in the delivery room (DR) to give them CPAP. However, applying a face mask may inhibit spontaneous breathing in newborns. In this study, premature babies will be randomly assigned to have a face mask routinely applied for CPAP shortly after birth; or to have a face mask selectively applied only for PPV if they are not breathing or have a slow heart beat in the first 5 minutes of life, or for CPAP if they have signs of respiratory distress after 5 minutes. The investigators will determine whether fewer participants who have the mask selectively applied receive PPV in the DR.
Study Details
Timeline
Interventions
Face mask application for CPAP and/or PPV delivery