NCT01242462

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

Feasibility of Mid-frequency Ventilation in Newborn Infants With Respiratory Distress Syndrome (RDS): Crossover Pilot Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Hour – 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-08-01
• Completion: 2013-05-01
• First posted: 2010-11-17
• Last updated: 2014-06-02

Locations

1 site across 1 country: United States