Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | October 2011 |
| End Date: | December 2012 |
| Contact: | Ramachandra Bhat, MD |
| Email: | rbhat@peds.uab.edu |
| Phone: | 205 934 4680 |
Feasibility of Mid-frequency Ventilation in Newborn Infants With Respiratory Distress Syndrome (RDS): Crossover Pilot Trial
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.
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.
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