Registry of Preterm Newborns With Severe Pulmonary Hypertension

NCT ID: NCT03310346

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2022-07-02

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.

Conditions

Pulmonary Hypertension; Preterm Infant

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Minutes
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Kinsella, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

16-2491

Identifier Type: -

Identifier Source: org_study_id