Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Episodic Hypoxemia in Mechanically Ventilated Preterm Infants
Interventions
DEVICE

Sequence A: Conventional-Volume Guarantee

"This is a crossover study. Infants will be randomly assigned to one of two sequences.~In sequence A, the infant will undergo a 24-hour period of conventional mechanical ventilation followed by a 24 hour period of volume guarantee ventilation.~Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).~During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.~During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study."

DEVICE

Sequence B: Volume Guarantee-Conventional

"This is a crossover study. Infants will be randomly assigned to one of two sequences.~In sequence B, the infant will undergo a 24-hour period of volume guarantee ventilation followed by a 24 hour period of conventional mechanical ventilation.~Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).~During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.~During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study."

Trial Locations (1)

33136

Newborn Intensitve Care Unit at Holtz Children's Hospital of Jackson Health System, Miami

All Listed Sponsors
lead

University of Miami

OTHER

NCT01727505 - Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia | Biotech Hunter | Biotech Hunter