Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

May 31, 2013

Conditions
Respiratory Distress Syndrome, Newborn
Interventions
PROCEDURE

Conventional Pressure Controlled SIMV

Initial ventilatory settings per clinical physician's discretion-tcCO2 \& Saturation (SAT) monitoring. Adjust vent setting approximately every 15min with a goal of: SAT 88-95%, tcCO2 45-55, pH greater than or equal to 7.25. Once goals reached, ventilatory strategy will crossed over to other intervention.

OTHER

Mid-frequency Ventilation

Ventilatory parameters include: max possible rate between 61-150 breaths/min; Shortest inspiration time (Ti) and expiration time (Te), but completed inspiration and expiration on pulmonary graphics. Stepwise weaning of PIP by 1 cm H20 to maintain tcCO2 at baseline. If measured PEEP - delivered PEEP generated is \>/= to 1cm H2O, PEEP is reduced to baseline value. Adjustments will be made to PIP, then rate for pH and CO2 changes; FiO2, then PIP for FiO2 changes. Target goal blood gas parameters (same as baseline) Saturations 88-95%; tcCO2 45-55 mmHG; pH \>/= 7.25. Maximum period of 2 hours. When goals met, or 2 hours in period, reverted back to SIMV at baseline settings

Trial Locations (1)

35243

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER

NCT01242462 - Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial | Biotech Hunter | Biotech Hunter