Lung Injury Clinical Trial
Official title:
Pulmonary Mechanics in Preterm Infants Treated With Heated Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure.
This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.
Respiratory distress and the need for respiratory support continues to be a common problem
for preterm infants. Presence of the breathing tube and duration of respirator provided
breaths have been shown to be associated with increased risk for secondary lung injury and
subsequent development of chronic lung disease of prematurity. Early application of
noninvasive nasal continuous positive airway pressure (NCPAP) has been shown to be an
effective, non-invasive, mode of respiratory support in preterm infants and to be associated
with a lower incidence of chronic lung disease. A recently published large randomized
multicenter study concluded that, among infants born at 28 weeks and longer gestation,
heated humidified high flow nasal cannula (HHHFNC) had similar clinical efficacy and safety
as compared to NCPAP. Both NCPAP and HHHFNC are currently used to assist infants with
breathing problems.
This study is designed to evaluate the effect of HHHFNC as compared to NCPAP on lung
function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation
requiring continuing respiratory support. In this study, infants will remain on the assigned
treatment of either NCPAP or HHHFNC until they require more support as provided by a
respirator or until a treatment cross-over from NCPAP to HHHFNC, or the reverse, as decided
by their attending physician. The infant's respiratory support will be managed according to
his/her attending doctor as per accepted standards of care. A pulmonary function test will
be performed twice weekly on each enrolled infant while receiving either NCPAP or HHHFNC
support, followed-up by once weekly lung function measurements post respiratory support
while infants are breathing only room air until discharge.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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