Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT00551642
• Date of registration: 30/10/2007
• Prospective Registration: No
• Primary sponsor: Mallinckrodt
• Public title: Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
• Scientific title: The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants
• Date of first enrolment: May 29, 2005
• Target sample size: 800
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00551642
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

Belgium, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Contacts

• Name: Clinical Team Leader
• Affiliation: Mallinckrodt

Key inclusion & exclusion criteria

Inclusion Criteria:

- Inborn preterm infants 24+0 weeks-28+6 days weeks gestational age (defined by first
trimester ultrasound or if not available based on the last menstrual period) who
requires the use of surfactant within 24 hours of birth (either prophylactically, or
for signs of developing respiratory distress), or who requires the use of continuous
positive airway pressure (CPAP) (fraction of inspired oxygen concentration (FiO2) =
0.30 on a mean airway pressure = 4cm water (H2O)) within 24 hours of birth in order to
maintain an oxygen saturation (SpO2) = 85%.

- Informed consent of the guardian.

Exclusion Criteria:

- Outborn infants.

- Infants = 29 weeks gestational age.

- Infants requiring FiO2 >0.5 to maintain SpO2 >85%, on a sufficient mean airway
pressure (e.g., > 8 cm H2O on controlled mechanical ventilation (CMV)) in order to
achieve adequate chest inflation (8-9 ribs on Chest X-ray) two hours after the proper
administration of exogenous surfactant.

- Any suspected congenital heart disease other than patent ductus arteriosus or atrial
septal defect.

- Any infant with severe bleeding or coagulation abnormalities at high-risk of
diathesis, e.g., platelet <50,000 per millimeter cube (mm³), fibrinogen <0.5 gram per
liter (g/L), other clotting factors <10%.

- Any infant in whom a decision has been made not to provide full treatment, e.g.,
chromosomal abnormalities, severe multiple abnormalities, severe birth asphyxia, etc.

- Use of another investigational drug or device before or during the active study
period.



Age minimum: N/A
Age maximum: 26 Hours
Gender: All

Health Condition(s) or Problem(s) studied

Lung Disease

Intervention(s)

Drug: Placebo

Drug: Nitric oxide

Primary Outcome(s)

Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress [Time Frame: 21 days]

Secondary ID(s)

INOT27

2004-002312-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/10/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00551642