- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310346
Registry of Preterm Newborns With Severe Pulmonary Hypertension
March 2, 2023 updated by: University of Colorado, Denver
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
232
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Premature newborns and their mothers recruited from up to 100 neonatal intensive care units
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
Occurrence of death
|
From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
Cause of death
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
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
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
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
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
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)
Time Frame: At 36 weeks after birth
|
BPD classification
|
At 36 weeks after birth
|
Development of Necrotizing Enterocolitis (NEC)
Time Frame: From birth through surgical repair of NEC, assessed up to one year
|
Occurrence of surgical repair of NEC
|
From birth through surgical repair of NEC, assessed up to one year
|
Development of Early Bacterial Sepsis
Time Frame: From Birth through 3 days of life
|
Early Occurrence of Bacterial sepsis, e.g. 3 days or less
|
From Birth through 3 days of life
|
Development of Late Bacterial Sepsis
Time Frame: 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
|
From Day 4 of life through hospital discharge or death, whichever occurs first, assessed up to one year
|
Intracranial hemorrhage
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
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)
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
Occurrence of PVL
|
From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
Surgery for Retinopathy of Prematurity (ROP)
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
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
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
Occurrence of surgical repair of PDA
|
From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
Pneumothorax
Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
Occurrence of pneumothorax
|
From birth through hospital discharge or death, whichever occurs first, assessed up to one year
|
Neurological Exam
Time Frame: 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
|
The most recent exam immediately prior to discharge or death, whichever occurs first, assessed up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John P Kinsella, MD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
July 2, 2022
Study Completion (Actual)
July 2, 2022
Study Registration Dates
First Submitted
September 15, 2017
First Submitted That Met QC Criteria
October 10, 2017
First Posted (Actual)
October 16, 2017
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 2, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-2491
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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