Clinical Trial: Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Feasibility of Mid-frequency Ventilation in Newborn Infants With Respiratory Distress Syndrome (RDS): Crossover Pilot Trial
Brief Summary: Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm infants. Despite improved survival of extremely premature infants with RDS, complications related to mechanical ventilation still occur. This trial will attempt to maintain adequate gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak inspiratory pressure in infants with respiratory distress requiring mechanical ventilation. A cross over design will be used to test the hypothesis whether mid-frequency ventilation in preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory pressure requirement when compared to conventional mechanical ventilation.
Detailed Summary:
Sponsor: University of Alabama at Birmingham
Current Primary Outcome: Average delta pressure [ Time Frame: 4 hours ]
Original Primary Outcome: Mean peak inspiratory pressure [ Time Frame: Less than 4 hours ]
Current Secondary Outcome:
- Average Mean Airway Pressure (MAP) [ Time Frame: Less than 4 hours ]Comparison of mean airway pressure between 2 periods of ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation
- Mean arterial pressure [ Time Frame: Less than 4 hours ]Comparison of mean arterial pressure during two periods of mechanical ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation
- Average delta pressure [ Time Frame: Less than 4 hours ]Comparison of average delta pressure during the two periods of mechanical ventilation-(A)Conventional ventilation strategy and (B)Mid-frequency ventilation
Original Secondary Outcome:
- Average Mean Airway Pressure [ Time Frame: Less than 4 hours ]Comparison of mean airway pressure between 2 periods of ventilation-first period of conventional mechanical ventilation and the second period of mid-frequency ventilation
- Mean arterial pressure [ Time Frame: Less than 4 hours ]Comparison of mean arterial pressure during two periods of mechanical ventilation-first period on conventional mechanical ventilation and second period on mid-frequency ventilation
Information By: University of Alabama at Birmingham
Dates:
Date Received: November 15, 2010
Date Started: October 2011
Date Completion:
Last Updated: May 29, 2014
Last Verified: May 2014