Registry Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide
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 participants 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.
- Premature and Term-near-term Neonates With Pulmonary Hypertension
- Eligible Ages
- Between 27 Weeks and 40 Weeks
- Eligible Genders
- Accepts Healthy Volunteers
- Was either a P neonate born at least 27 weeks to less than 34 weeks of GA or a TNT neonate born at least 34 weeks but no more than 40 weeks of GA.
- Was administered INOMAX therapy after birth to 7 days of age via any route (invasive or noninvasive ventilation) for a minimum treatment period of at least 24 hours up to 96 ±12 hours. The participants may receive Inomax for a longer period.
- Had PH, as confirmed by echocardiogram or a differential saturation gradient of at least 10%.
- Received INOMAX administration as part of routine clinical practice in a Level III or higher neonatal intensive care unit in the United States.
- Has all variables required to calculate OI or SOI (a baseline sample prior to treatment and 4 samples obtained during treatment).
- Was at risk of imminent death (death expected within 24 hours).
- Received extracorporeal membrane oxygenation (ECMO).
- Had a life-threatening abnormality (cranial, cardiac, thoracic), chromosomal abnormality, congenital diaphragmatic hernia, congenital heart defect (other than patent ductus arteriosus or small atrial septal defect).
- Had been resuscitated requiring chest compressions within 6 hours of receiving INOMAX.
- Had Grade IV bilateral intraventricular hemorrhage or periventricular leukomalacia.
- Had active uncontrolled bleeding.
- Had disseminated intravascular coagulopathy.
- Had active seizures while receiving anticonvulsants.
- Experienced prolonged asphyxia with evidence of severe acidosis (pH < 7.25).
- Received concomitant pulmonary vasodilator therapy (eg, prostacyclin or sildenafil) except when sildenafil was used to wean the participant from INOMAX therapy.
- Study Type
- Observational Model
- Time Perspective
|Premature (P) Neonates||84 P neonates (at least 27 weeks but less than 34 weeks of gestational age [GA])||
|Term-Near-Term (TNT) Neonates||84 TNT neonates >34 weeks of age||
- NCT ID
Study ContactAnne Marie Viola