Clinical trial NCT01503801: Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia
Official title: Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulmonary Disease
Keywords: Preterm neonates
Bronchopulmonary dysplasia
Chronic lung disease
Inhaled nitric oxide
Respiratory therapy
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Fudan University
name: Children's Hospital of Hebei Province
name: Shen-Zhen City Maternity and Child Healthcare Hospital
name: Hunan Children's Hospital
name: QuanZhou Women and Children's Hospital
name: The First Affiliated Hospital of Xiamen University
name: Xiamen Women's and Children's Hospital
First posted: 2012-01-04
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death or Bronchopulmonary Dysplasia
timeFrame: Before discharge or at 36 weeks post-conceptional age
Secondary outcomes:
measure: Intraventricular Hemorrhage Grade III and IV
timeFrame: At 36 weeks post-conceptional age
measure: Days on assisted ventilation
timeFrame: Before discharge
measure: Length of oxygen therapy
timeFrame: Before discharge
measure: Retinopathy of prematurity
timeFrame: Before discharge
measure: Cost of hospital and NICU stay
timeFrame: Before discharge
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Bo Sun, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: