WithdrawnNot Applicable

Predictors of Inhaled Nitric Oxide Responsiveness in Patients With PPHN

Stopped: No patients were enrolled

0Started 2021-07-15

Plain-language 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 with response to iNO therapy. We will evaluate related biomarkers at various time-points during disease progression and in response to therapy, including single nucleotide polymorphisms in the cyclic adenosine monophosphate/cyclic guanosine monophosphate-Phosphodiesterase (PDE) pathway, indicators of metabolic dysregulation and inflammation, as well as biochemical markers of heart strain. We will perform targeted neonatal echocardiograms to evaluate severity of PPHN and heart function both as an added clinical biomarker and to follow disease progression.

Who can participate

Age range10 Days

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

Biomarker Identification

Timeframe: 24 hours after enrollment

Trial details

NCT IDNCT06043635

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-01

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