Registry of Preterm Newborns With Severe Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Prospective Multicenter Registry for Preterm Newborns With Severe Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310346
• Other study ID #: 16-2491
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: July 2, 2022

Study information

• Verified date: March 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: July 2, 2022
• Est. primary completion date: July 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Minutes to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Premature Birth
• Preterm Infant
• Pulmonary Hypertension

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Occurrence of death	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Primary	Cause of death	The cause, if death occurred	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary	Number of Days Hospitalized	Total number of days in hospital	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary	Number of Days on Ventilation	Total number of days on mechanical ventilation	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary	Classification of Bronchopulmonary Dysplasia (BPD)	BPD classification	At 36 weeks after birth
Secondary	Development of Necrotizing Enterocolitis (NEC)	Occurrence of surgical repair of NEC	From birth through surgical repair of NEC, assessed up to one year
Secondary	Development of Early Bacterial Sepsis	Early Occurrence of Bacterial sepsis, e.g. 3 days or less	From Birth through 3 days of life
Secondary	Development of Late Bacterial Sepsis	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
Secondary	Intracranial hemorrhage	Occurrence and severity of intracranial hemorrhage	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary	Cystic Periventricular Leukomalacia (PVL)	Occurrence of PVL	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary	Surgery for Retinopathy of Prematurity (ROP)	Occurrence of surgical repair of ROP	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary	Patent Ductus Arteriosus (PDA) Ligation	Occurrence of surgical repair of PDA	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary	Pneumothorax	Occurrence of pneumothorax	From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Secondary	Neurological Exam	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