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Registry of Preterm Newborns With Severe Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03310346
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
University of Colorado, Denver

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).

Condition or disease
Pulmonary Hypertension Preterm Infant

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Multicenter Registry for Preterm Newborns With Severe Pulmonary Hypertension
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mortality [ Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year ]
    Occurrence of death

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Classification of Bronchopulmonary Dysplasia (BPD) [ Time Frame: At 36 weeks after birth ]
    BPD classification

  4. 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

  5. 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

  6. 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

  7. 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

  8. Cystic Periventricular Leukomalacia (PVL) [ Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year ]
    Occurrence of PVL

  9. 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

  10. 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

  11. Pneumothorax [ Time Frame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year ]
    Occurrence of pneumothorax

  12. 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



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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature newborns and their mothers recruited from up to 100 neonatal intensive care units
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310346


Contacts
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Contact: John P Kinsella, MD 303-724-2834 john.kinsella@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: John P Kinsella, MD    303-724-2853    john.kinsella@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Mallinckrodt
Investigators
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Principal Investigator: John P Kinsella, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03310346     History of Changes
Other Study ID Numbers: 16-2491
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Premature Birth
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases