Status:
WITHDRAWN
Predictors of Inhaled Nitric Oxide Responsiveness in Patients With PPHN
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
PPHN
Hypoxic Respiratory Failure
Eligibility:
All Genders
Up to 10 years
Brief Summary
To identify biochemical, clinical, or genetic biomarkers that may predict responsiveness to iNO in neonates with PPHN/HRF. The primary outcome will be identification of any biomarker(s) associated wit...
Detailed Description
A single-center, prospective observational cohort study evaluating potential biochemical, clinical, and/or genetic biomarkers in neonates admitted with a diagnosis of PPHN that may predict iNO respons...
Eligibility Criteria
Inclusion
- Greater than 34 weeks gestational age.
- Less than or equal to 10 postnatal days of age.
- Echocardiographic evidence of PPHN (right-to-left or bidirectional shunt at the foramen ovale or the ductus arteriosus and/or severe tricuspid regurgitation)
Exclusion
- Lethal congenital anomalies, obvious syndromic or chromosomal disorders.
- Congenital diaphragmatic hernia.
- Congenital heart defect (except a small atrial septal defect, ventricular septal defect, and/or PDA).
Key Trial Info
Start Date :
July 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06043635
Start Date
July 15 2021
End Date
December 1 2022
Last Update
September 21 2023
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