Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

Pulmonary Disease Clinical Trial

— NO-BPD  

Official title:

Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503801
• Other study ID #: FudanU
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 19, 2011
• Last updated: January 24, 2013
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Pulmonary Disease

Intervention

Drug:
• Nitric 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

Device:
• respiratory support
Routine respiratory support.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Fudan University	Children's Hospital of Fudan University, Hebei Provincial Children's Hospital, Hunan Children's Hospital, QuanZhou Women and Children's Hospital, Shen-Zhen City Maternity and Child Healthcare Hospital, The First Affiliated Hospital of Xiamen University, Xiamen Women's and Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Days on assisted ventilation	Days on assisted ventilation before discharge	Before discharge	No
Secondary	Length of oxygen therapy	Length of oxygen therapy before discharge	Before discharge	No
Secondary	Retinopathy of prematurity	Retinopathy of prematurity before discharge	Before discharge	Yes
Secondary	Cost of hospital and NICU stay	Medical cost of hospital and NICU stay	Before discharge	No