Status:
COMPLETED
Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
1-7 years
Phase:
PHASE1
PHASE2
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 v...
Eligibility Criteria
Inclusion
- 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% FiO2.
- Written informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01242462
Start Date
October 1 2011
End Date
May 1 2013
Last Update
June 2 2014
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35243