Pulmonary HypertensionNCT03310346
Registry of Preterm Newborns With Severe Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Preterm Infant, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 minutes to 45 years
- Conditions the study is for
- Pulmonary Hypertension, Preterm Infant
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 2 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Premature newborns and their mothers recruited from up to 100 neonatal intensive care units
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Medical subject headings
- Hypertension, Pulmonary, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Occurrence of death
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Cause of death
The cause, if death occurred
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary outcomes (12)
Number of Days Hospitalized
Total number of days in hospital
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Number of Days on Ventilation
Total number of days on mechanical ventilation
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Classification of Bronchopulmonary Dysplasia (BPD)
BPD classification
Measured: At 36 weeks after birth
Development of Necrotizing Enterocolitis (NEC)
Occurrence of surgical repair of NEC
Measured: From birth through surgical repair of NEC, assessed up to one year
Development of Early Bacterial Sepsis
Early Occurrence of Bacterial sepsis, e.g. 3 days or less
Measured: From Birth through 3 days of life
Development of Late Bacterial Sepsis
Late Occurrence of Bacterial sepsis, e.g. >3 days
Measured: From Day 4 of life through hospital discharge or death, whichever occurs first, assessed up to one year
Intracranial hemorrhage
Occurrence and severity of intracranial hemorrhage
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Cystic Periventricular Leukomalacia (PVL)
Occurrence of PVL
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Surgery for Retinopathy of Prematurity (ROP)
Occurrence of surgical repair of ROP
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Patent Ductus Arteriosus (PDA) Ligation
Occurrence of surgical repair of PDA
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Pneumothorax
Occurrence of pneumothorax
Measured: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Neurological Exam
Results of neurological exam: Normal, Abnormal, Suspect
Measured: The most recent exam immediately prior to discharge or death, whichever occurs first, assessed up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Aug 2017
- Primary completion2 Jul 2022
- Study completion2 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- John P Kinsella, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310346
- Sponsor's protocol ID
- 16-2491
- Status last verified
- Mar 2023
- First submitted
- 15 Sep 2017
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry for Preterm Newborns With Severe Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03310346
- Acronym / sponsor ID
- 16-2491
- Conditions
- Pulmonary Hypertension, Preterm Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 2 Jul 2022 (actual)
- Study completion
- 2 Jul 2022 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 minutes to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Premature newborns and their mothers recruited from up to 100 neonatal intensive care units
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Occurrence of death
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
12 secondary outcomes
Number of Days Hospitalized
Time frame: 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
Classification of Bronchopulmonary Dysplasia (BPD)
Time frame: At 36 weeks after birth
Development of Necrotizing Enterocolitis (NEC)
Time frame: 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
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
Intracranial hemorrhage
Time frame: 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
Surgery for Retinopathy of Prematurity (ROP)
Time frame: 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
Pneumothorax
Time frame: 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 and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Kinsella, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Preterm Infant, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.