Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. When this happens, the heart has to work harder to pump the blood through. Some babies are born with pulmonary hypertension (PH). Doctors might use INOmax (a gas the baby breathes) to help newborn babies (neonates) with PH. This study will use information from the records of registered babies to see how effective and safe INOmax is for treating premature and other newborn babies for up to 11 days after they are born.

Official Title
-----------------
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 Ventilation

Conditions
-----------------
Pulmonary Hypertension of Newborn

Intervention / Treatment
-----------------
* Drug: INOmax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Was either a P neonate born at least 27 weeks to less than 34 weeks of gestational age (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). Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 27 Weeks
Maximum Age: 40 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| P Neonates<br>Premature (P) neonates [at least 27 weeks but less than 34 weeks of gestational age] | Drug: INOmax<br>* Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation<br>|
| TNT Neonates<br>Term-Near-Term (TNT) neonates at least 34 weeks of gestational age | Drug: INOmax<br>* Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates with significant response to INOmax treatment within each age group | Significant response is defined as at least a 25% improvement from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOMAX treatment | within 108 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates with significant response to Inomax treatment within each age group and severity group | The severity of pulmonary hypertension (PH) is classified for each participant Categories: Mild, Moderate, Severe | within 108 hours | 
| Time to reach significant response to Inomax treatment within each age group and severity group | The median time to INOmax complete response (25% improvement) for neonates with each baseline PH severity classification Categories: Mild, Moderate, Severe | within 108 hours | 
| Number of neonates with partial response to INOmax treatment within each age group and severity group | Partial response is defined as less than a 25% improvement in OI/SOI during INOmax treatment | within 108 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature and term-near-term neonates