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

The University of Alabama at Birmingham

Status and phase

Completed

Phase 2

Phase 1

Conditions

Respiratory Distress Syndrome, Newborn

Treatments

Procedure: Conventional Pressure Controlled SIMV

Other: Mid-frequency Ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT01242462

UAB NEO 002

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

1 hour to 7 days old

Volunteers

No Healthy Volunteers

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% FiO2.
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.