Multicenter, Prospectively Defined Observational Registry With Retrospective Data Collection, Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide via Invasive or Noninvasive Ventilator Support at ...

Service: Trial Number:
750-17
Principal Investigator: Conducted at:
Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes
Age Range:
27 Weeks to 40 Weeks
Gender:
Male & Female

This is a multicenter, prospectively defined, observational registry study evaluating the use of inhaled nitric oxide (INOMAX) in 84 Premature (P) neonates (at least 27 weeks but less than 34 weeks of gestational age [GA]) and 84 Term-Near-Term (TNT) neonates (at least 34 weeks to no more than 40 weeks of GA), with Pulmonary Hypertension (PH). The 2 groups will have a similar number of subjects by severity (mild, moderate, and, severe) and evaluated for response to INOMAX during a treatment period of up to 96 hours ± 12 hours and a safety follow-up through 7 days (for a total of up to 11 days) or to hospital discharge, whichever comes first.

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