Registry of Preterm Newborns With Severe Pulmonary Hypertension
Prospective Multicenter Registry for Preterm Newborns With Severe Pulmonary Hypertension
1 other identifier
observational
232
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
October 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2022
CompletedMarch 6, 2023
March 1, 2023
4.9 years
September 15, 2017
March 2, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (12)
Number of Days Hospitalized
From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Number of Days on Ventilation
From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Classification of Bronchopulmonary Dysplasia (BPD)
At 36 weeks after birth
Development of Necrotizing Enterocolitis (NEC)
From birth through surgical repair of NEC, assessed up to one year
Development of Early Bacterial Sepsis
From Birth through 3 days of life
- +7 more secondary outcomes
Eligibility Criteria
Premature newborns and their mothers recruited from up to 100 neonatal intensive care units
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Mallinckrodtcollaborator
Study Sites (1)
University of Colorado
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John P Kinsella, MD
University of Colorado, Denver
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2017
First Posted
October 16, 2017
Study Start
August 1, 2017
Primary Completion
July 2, 2022
Study Completion
July 2, 2022
Last Updated
March 6, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share