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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01503801
Other study ID # FudanU
Secondary ID
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


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
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