Pulmonary Disease
Conditions
Keywords
Preterm neonates, Bronchopulmonary dysplasia, Chronic lung disease, Inhaled nitric oxide, Respiratory therapy
Brief summary
Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will: 1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death 2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect
Detailed description
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.
Interventions
DRUGNitric Oxide
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
DEVICErespiratory support
Routine respiratory support.
Sponsors
Children's Hospital of Fudan University
Children's Hospital of Hebei Province
Shen-Zhen City Maternity and Child Healthcare Hospital
Hunan Children's Hospital
QuanZhou Women and Children's Hospital
The First Affiliated Hospital of Xiamen University
Xiamen Women's and Children's Hospital
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 30 Days
Healthy volunteers
No
Inclusion criteria
* GA\<=34w,less than 7 days of age,oxygenation index (OI) of more than 10 after being ventilated for more than 48 hours or surfactant therapy * GA\<=34w,between 7 to 30 days of age, requiring assisted ventilator or nasal continuous positive airway pressure for more than 2 days
Exclusion criteria
* lethal congenital anomalies or congenital heart disease (including an atrial septal defect larger than 1 cm and a ventricular septal defect larger than 2 mm) * active pulmonary hemorrhage, unevaluated pneumothorax * preexisting bilateral grade 3-4 intraventricular hemorrhage * a platelet count \<100\*10\^9/l * an expected duration of ventilation of less than 48 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death or Bronchopulmonary Dysplasia | Before discharge or at 36 weeks post-conceptional age | the incidence of death before discharge or BPD at 36 weeks post-conceptional age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraventricular Hemorrhage Grade III and IV | At 36 weeks post-conceptional age | the incidence of Intraventricular Hemorrhage Grade III and IV At 36 weeks post-conceptional age |
| Days on assisted ventilation | Before discharge | Days on assisted ventilation before discharge |
| Length of oxygen therapy | Before discharge | Length of oxygen therapy before discharge |
| Retinopathy of prematurity | Before discharge | Retinopathy of prematurity before discharge |
| Cost of hospital and NICU stay | Before discharge | Medical cost of hospital and NICU stay |
Countries
China
Outcome results
None listed