Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Windtree Therapeutics
With
National Heart, Lung, and Blood Institute (NHLBI)
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Informed consent from a legally authorized representative
Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
Successful implementation of controlled nCPAP within 90 minutes after birth
Spontaneous breathing
Chest radiograph consistent with RDS
Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth
You may not be if
Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
A 5 minute Apgar score \< 5
Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
Known or suspected chromosomal abnormality or syndrome
Prolong rupture of membranes (PROM) \> 2 weeks
Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
Need for endotracheal intubation and mechanical ventilation
Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth
