Clinical trial NCT03310346: Registry of Preterm Newborns With Severe Pulmonary Hypertension
Official title: Prospective Multicenter Registry for Preterm Newborns With Severe Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Preterm Infant
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2017-10-16
Enrollment: 232
Sex: ALL
Minimum age (years): 0
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature newborns and their mothers recruited from up to 100 neonatal intensive care units

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.

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

Primary outcomes:
measure: Mortality
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Cause of death
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary outcomes:
measure: Number of Days Hospitalized
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Number of Days on Ventilation
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Classification of Bronchopulmonary Dysplasia (BPD)
timeFrame: At 36 weeks after birth
measure: Development of Necrotizing Enterocolitis (NEC)
timeFrame: From birth through surgical repair of NEC, assessed up to one year
measure: Development of Early Bacterial Sepsis
timeFrame: From Birth through 3 days of life
measure: Development of Late Bacterial Sepsis
timeFrame: From Day 4 of life through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Intracranial hemorrhage
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Cystic Periventricular Leukomalacia (PVL)
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Surgery for Retinopathy of Prematurity (ROP)
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Patent Ductus Arteriosus (PDA) Ligation
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Pneumothorax
timeFrame: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
measure: Neurological Exam
timeFrame: The most recent exam immediately prior to discharge or death, whichever occurs first, assessed up to one year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: John P Kinsella, MD
role: PRINCIPAL_INVESTIGATOR
References: