Preterm Infant, Pulmonary Hypertension
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Mallinckrodt
University of Colorado, Denver
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Minutes to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | Occurrence of death |
| Cause of death | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | The cause, if death occurred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days on Ventilation | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | Total number of days on mechanical ventilation |
| Classification of Bronchopulmonary Dysplasia (BPD) | At 36 weeks after birth | BPD classification |
| Development of Early Bacterial Sepsis | From Birth through 3 days of life | Early Occurrence of Bacterial sepsis, e.g. 3 days or less |
| Development of Late Bacterial Sepsis | From Day 4 of life through hospital discharge or death, whichever occurs first, assessed up to one year | Late Occurrence of Bacterial sepsis, e.g. \>3 days |
| Intracranial hemorrhage | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | Occurrence and severity of intracranial hemorrhage |
| Development of Necrotizing Enterocolitis (NEC) | From birth through surgical repair of NEC, assessed up to one year | Occurrence of surgical repair of NEC |
| Surgery for Retinopathy of Prematurity (ROP) | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | Occurrence of surgical repair of ROP |
| Patent Ductus Arteriosus (PDA) Ligation | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | Occurrence of surgical repair of PDA |
| Pneumothorax | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | Occurrence of pneumothorax |
| Neurological Exam | The most recent exam immediately prior to discharge or death, whichever occurs first, assessed up to one year | Results of neurological exam: Normal, Abnormal, Suspect |
| Cystic Periventricular Leukomalacia (PVL) | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | Occurrence of PVL |
| Number of Days Hospitalized | From birth through hospital discharge or death, whichever occurs first, assessed up to one year | Total number of days in hospital |
Countries
United States
Outcome results
None listed