Hypoxic respiratory failure
Conditions
Interventions
Nitric oxide group:Continuous nitric oxide therapy was administered in very premature infants with hypoxic respiratory failure, adjusted according to the experimental protocol.
Placebo inhalation control group:Equal-volume placebo inhalation was given in very preterm infants with hypoxic respiratory failure.
Sponsors
The Second Hospital of Shandong Universit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: Very low birth weight infants (<1500g) with an initial treatment age (including corrected age) of =32w, 5-28 days after birth 2: Infants hospitalized in the neonatal intensive care unit and receiving respiratory support for hypoxic respiratory failure 3: The guardian fully understands the benefits and risks of this trial and is still willing to participate, and has signed an informed consent.
Exclusion criteria
Exclusion criteria: 1: Congenital heart disease with severe left heart dysplasia 2: Methemoglobin reductase deficiency or methemoglobinemia has been confirmed 3: Life-threatening diseases such as grade III or higher intracranial hemorrhage, inherited metabolic diseases, and severe deformities before iNO 4: Previous iNO treatment or combined use of the same type of drugs 5: Participants in other drug or medical device clinical trials 6: Subjects who are deemed inappropriate for this clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygenation Index, OI;Incidence and mortality of bronchopulmonary dysplasia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Respiratory support time;Total hospital stay;Settings of ventilation;Oxygen therapy time;Incidence of necrotizing enterocolitis in newborns;Incidence of retinopathy of prematurity;Incidence of intraventricular hemorrhage;Incidence of sepsis or septicemia;Incidence of patent ductus arteriosus requiring medical or surgical treatment;Incidence of adverse events;Incidence of methemoglobinemia;Nitrogen dioxide excess incidence;Results in blood gas analysis; | — |
Countries
China
Contacts
Public ContactJiang Xue
The Second Hospital of Shandong University
Outcome results
None listed