Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital of Fudan University | OTHER |
| Children's Hospital of Hebei Province | OTHER |
| Shen-Zhen City Maternity and Child Healthcare Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will:
Bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (NICU) all over the world. This multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with developing bronchopulmonary dysplasia.
Infants were followed until death or discharge to home. The trial will compare iNO therapy to conventional management strategies (including treatment with nasal continuous positive airway pressure (CPAP), surfactant and high frequency ventilation as adjuncts to iNO therapy) as the control.
During the initial dosing, iNO was started at 5 ppm and could be decreased to 1-2 ppm. The Infants would inhale NO until weaned. Infants will be monitored for signs of toxicity due to cumulated dosage of NO and its metabolites, such as methemoglobin, and nitrite and nitrate in blood and urine, and nitrogen dioxide in ventilator circuit to the patient.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inhaled nitric oxide | Experimental | The preterm infants in the experimental group inhaled nitric oxide |
|
| oxygen | Active Comparator | The preterm infants enrolled but subjected to routine respiratory support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | Drug | The infants in experimental group will receive inhale nitric oxide initiated at 5 ppm for 24 h followed by 2 ppm for 6 days or until weaning off |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death or Bronchopulmonary Dysplasia | the incidence of death before discharge or BPD at 36 weeks post-conceptional age | Before discharge or at 36 weeks post-conceptional age |
| Measure | Description | Time Frame |
|---|---|---|
| Intraventricular Hemorrhage Grade III and IV | the incidence of Intraventricular Hemorrhage Grade III and IV At 36 weeks post-conceptional age | At 36 weeks post-conceptional age |
| Days on assisted ventilation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bo Sun, Ph.D | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
Not provided
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| D045462 | Endothelium-Dependent Relaxing Factors |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
Not provided
Not provided
| Hunan Children's Hospital |
| OTHER_GOV |
| QuanZhou Women and Children's Hospital | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Xiamen Women's and Children's Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| respiratory support | Device | Routine respiratory support. |
|
|
Days on assisted ventilation before discharge
| Before discharge |
| Length of oxygen therapy | Length of oxygen therapy before discharge | Before discharge |
| Retinopathy of prematurity | Retinopathy of prematurity before discharge | Before discharge |
| Cost of hospital and NICU stay | Medical cost of hospital and NICU stay | Before discharge |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |