Registry of Preterm Newborns With Severe Pulmonary Hypertension

Study Overview
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Brief Summary
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The purpose of this prospective research registry is to collect data on treatment strategies and outcomes for premature newborns with severe pulmonary hypertension (PH).

Detailed Description
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There is a lack of consensus on the role of inhaled nitric oxide (iNO) therapy and other pulmonary vasodilators for the treatment of severe pulmonary hypertension (PH) in premature newborns (<34 weeks gestation). However, a proper randomized, controlled trial of iNO in premature newborns with severe PH has not been completed. Some practices embrace the American Academy of Pediatrics (AAP) statement that there is no condition for which iNO should be used in the premature newborn, and others selectively treat premature infants with inhaled nitric oxide (iNO) who suffer life threatening hypoxemia due to suprasystemic PH and right-to-left veno-arterial admixture across the arterial duct and/or oval foramen. The number of neonatal intensive care units (NICUs) adopting each of these approaches is currently unknown, but it is possible that the former group is increasing due to administrative pressure to reduce uncompensated off-label iNO use. A prospective registry collection of treatment strategies and outcomes for this subset of premature newborns will help define current treatment strategies and yield important information about safety and efficacy of the different approaches to management, and would inform the debate more effectively than a series of iNO treated infants alone. Data collected includes maternal age, race/ethnicity, pregnancy and delivery complications, prenatal medications, infant characteristics such as Apgar scores, birthweight, congenital anomalies, respiratory status, pharmacologic therapy used for PH and its side effects, and blood gas data. Up to 100 sites in North America will be invited to monitor for appropriate cases.

Official Title
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Prospective Multicenter Registry for Preterm Newborns With Severe Pulmonary Hypertension

Conditions
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Pulmonary Hypertension, Preterm Infant

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature newborns 23-34 weeks gestation Echocardiographic evidence showing systemic or suprasystemic levels of PH, or > 5% difference in pre-post ductal saturation if echo is not available. Fraction of inspired oxygen (FiO2) >0.60 in the first 72 hours after birth Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 0 Minutes
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Occurrence of death | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Cause of death | The cause, if death occurred | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days Hospitalized | Total number of days in hospital | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Number of Days on Ventilation | Total number of days on mechanical ventilation | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Classification of Bronchopulmonary Dysplasia (BPD) | BPD classification | At 36 weeks after birth | 
| Development of Necrotizing Enterocolitis (NEC) | Occurrence of surgical repair of NEC | From birth through surgical repair of NEC, assessed up to one year | 
| Development of Early Bacterial Sepsis | Early Occurrence of Bacterial sepsis, e.g. 3 days or less | From Birth through 3 days of life | 
| Development of Late Bacterial Sepsis | Late Occurrence of Bacterial sepsis, e.g. >3 days | From Day 4 of life through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Intracranial hemorrhage | Occurrence and severity of intracranial hemorrhage | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Cystic Periventricular Leukomalacia (PVL) | Occurrence of PVL | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Surgery for Retinopathy of Prematurity (ROP) | Occurrence of surgical repair of ROP | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Patent Ductus Arteriosus (PDA) Ligation | Occurrence of surgical repair of PDA | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Pneumothorax | Occurrence of pneumothorax | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | 
| Neurological Exam | Results of neurological exam: Normal, Abnormal, Suspect | The most recent exam immediately prior to discharge or death, whichever occurs first, assessed up to one year |