Registry of Preterm Newborns With Severe Pulmonary Hypertension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Healthy:No
Age Range:Any - 45
Updated:10/19/2018
Start Date:August 1, 2017
End Date:August 1, 2023
Contact:John P Kinsella, MD
Email:john.kinsella@ucdenver.edu
Phone:303-724-2834

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Prospective Multicenter Registry for Preterm Newborns With Severe Pulmonary Hypertension

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

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.

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:
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Aurora, Colorado 80045
Phone: 303-724-2853
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