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Inhaled Nitric Oxide Treatment of Neonatal Pulmonary Arterial Hypertension

Safety and Efficacy of Inhaled Nitric Oxide Generated by an Instant Generation System for Treating Neonatal Pulmonary Arterial Hypertension with Respiratory Failure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070324
Enrollment
Unknown
Registered
2023-04-10
Start date
2023-04-10
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary arterial hypertension with respiratory faliure of newborn

Interventions

iNO treatment group:nitric oxide inhalation

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The following conditions are met: 1. evidence of pulmonary arterial hypertension on cardiac ultrasound 2. who are receiving invasive respiratory support 3. oxygenation index (OI) >= 20 4. the age at initial treatment is >= 34 weeks,including corrected gestational age 5. The guardian fully understands the benefits and risks of this study, and is still willing to participate and sign the informed consent

Exclusion criteria

Exclusion criteria: Comply with any of the following: 1. OI >= 40 2. Use Extracorporeal Membrane Oxygen (ECMO) 3. Severe left heart dysplasia or duct-dependent congenital heart disease 4. methemoglobinemia defined as having more than 1% methemoglobin in the blood has been established 5. Congenital cardiac dysplasia 6. Degree II and above intracranial hemorrhage existed before NO inhalation 7. Subjects who are participating in clinical trials of other drugs or medical devices that the investigator deems inappropriate to participate in this clinical trial 5. Incomplete data

Design outcomes

Primary

MeasureTime frame
OI at 1 h of iNO treatment;

Secondary

MeasureTime frame
OI at 24 h of iNO treatment;incidence of adverse events;OI at iNO is discontinued;Results in blood gas analysis;Settings of ventilation;Period of iNO application;Total hospital stay;Medical costs for hospitalization;Rate of discharge against medical advice;

Countries

China

Contacts

Public ContactHei Mingyan

Beijing Children's Hospital Affiliated to Capital Medical University

heimingyan@bch.com.cn+86 13370179319

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026