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 ]

Difference in peak inspiratory pressure (PIP) and peak end expiratory pressure (PEEP) (average delta pressure) during two time periods--time period on conventional synchronized intermittent ventilation (SIMV) and time period on mid-frequency ventilation, randomly assigned.


Original Primary Outcome: Mean peak inspiratory pressure [ Time Frame: Less than 4 hours ]

Difference in mean peak inspiratory pressure during two time periods--first time period on conventional SIMV and second time period on mid-frequency ventilation


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