Persistent pulmonary hypertension of newborn (PPHN)
Conditions
Interventions
Stepwise Decreasing Mode:Stepwise Decreasing Mode
Linear Decreasing Mode:Linear Decreasing Mode
Sponsors
Children's hospital of fudan university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed PPHN has been initiated or is expected to start iNO treatment >=24h; 2. Positive reaction to iNO; 3. Suitable and conditional use of iNO equipment with intelligent closed-loop offline function; 4. The guardian/legal representative fully understands the benefits and risks of this study, is still willing to participate, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Proven risk of contraindications to nitric oxide, including the following: (1) Severe hypoplasia of the left heart, or congenital heart disease dependent on the ductus arteriosus; (2) fatal congenital defects and congestive heart failure; (3) Congenital methemoglobinemia; (4) Severe hemorrhage, such as intracranial hemorrhage, intraventricular hemorrhage, pulmonary hemorrhage; 2. Combined with chronic lung disease and other refractory diseases, it is estimated that weaning cannot be initiated within 7 days of iNO treatment; 3. No positive reaction to iNO or no more than 30 minutes of use, no need to strictly descend the ladder to evacuate; 4. Use of iNO treatment concentrations greater than 20 ppm from initiation of iNO treatment to withdrawal; or NO withdrawal starting concentration less than 20ppm; 5. Participating in clinical trials of other drugs or medical devices; 6. The investigator thinks it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of rebound hypoxia;Duration of iNO weaning; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of times the device was alarmed during the evacuation process;The number of knob adjustments and the number of times the NO concentration is set during evacuation;Duration of mechanical ventilation;Incidence of NO-related adverse events;Incidence of comorbidities;Proportion of ECMO cases is used;Mortality before hospital discharge;Questionnaire scores on healthcare preferences; | — |
Countries
China
Contacts
Public ContactYuan Lin
Children’s Hospital of Fudan University
Outcome results
None listed