The Effects of Nitric Oxide for Inhalation on the development of chronic lung disease in pre-term infants. - INOT-27

INO Therapeutics0 sites800 target enrollmentFebruary 23, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress.
Sponsor: INO Therapeutics
Enrollment: 800
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

February 23, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

INO Therapeutics

•The patient must meet the following 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 CPAP (FiO2 \=
•0\.30 and mean airway pressure \= 4cm H2O) within 24 hours of birth in order to
•maintain an SpO2 \= 85%.
•Informed consent of the parent or legal guardian.
•CPAP \= Continuous Positive Airway Pressure
•SpO2 \= Oxygen saturation by pulse oximeter
•Are the trial subjects under 18? yes

•The patient will be excluded from enrollment if any of the following are true:
•Outborn infants.
•Infants \= 29 weeks gestational age.
•Infants with birth weight \<500 grams.
•Infants requiring FiO2 \>0\.5 to maintain SpO2 \>85%, on a sufficient mean airway
•pressure (e.g., \> 8 cm H2O on 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 suspected lung hypoplasia associated with congenital diaphragmatic hernia