Application for regulatory approval withdrawn

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.

Inclusion Criteria:

1. Birth weight greater than or equal to 1000 grams.

2. Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).

3. Candidate for non-invasive respiratory support as a result of:

   1. An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
   2. An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.

4. Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.

Exclusion Criteria:

1. Birth weight less than 1000 grams.
2. Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
3. Active air leak syndrome.
4. Subjects will not be eligible if they are not considered viable.
5. Infants with abnormalities of the upper and lower airways
6. Infants with significant abdominal or respiratory malformations .