Feasibility of Mid-frequency Ventilation in Newborn Infants With Respiratory Distress Syndrome (RDS): Crossover Pilot Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Respiratory Distress Syndrome, Newborn
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Average delta pressure
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Ramachandra Bhat, MD
Fellow Instructor, Department of Pediatrics, Division of Neonatology
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •Inborn newborn infants with birthweight greater than or equal to 500gms, with gestational age greater than or equal to 24 weeks but less than or equal to 36 weeks.
- •Postnatal age less than or equal to 7 days.
- •Infant with respiratory distress syndrome (RDS) on mechanical ventilation with less than or equal to 60 breaths/minute, initially requiring greater than or equal to 30% FiO
- •Written informed consent.
Exclusion Criteria
- •Blood culture positive sepsis, life threatening congenital anomalies, cyanotic congenital heart diseases, hydrops fetalis, outborn infants, non viability as determined by the attending physician, and newborns who are considered too unstable for study enrollment as per neonatology attending/fellow.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Average Mean Airway Pressure (MAP)(Less than 4 hours)
- Mean arterial pressure(Less than 4 hours)
- Average delta pressure(Less than 4 hours)