Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2004-002312-29-SE
EUCTR2004-002312-29-SE
Active, not recruiting
Not Applicable

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

INO Therapeutics0 sites800 target enrollmentStarted: January 12, 2005Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsINO max® (Nitric Oxide for Inhalation, 400 ppm)

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
INO Therapeutics
Enrollment
800
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Investigators

Sponsor
INO Therapeutics

Similar Trials

Active, not recruiting
Not Applicable
The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants.
EUCTR2004-002312-29-DEINO Therapeutics800
Active, not recruiting
Phase 1
The Effects of Nitric Oxide for Inhalation on the development of chronic lung disease in pre-term infants. - INOT-27Prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress.MedDRA version: 7.0 Level: LLT Classification code 10054933
EUCTR2004-002312-29-GBINO Therapeutics800
Active, not recruiting
Phase 1
The Effects of Nitric Oxide for Inhalation on the development of chronic lung disease in pre-term infants. - INOT-27Prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress.MedDRA version: 7.0Level: LLTClassification code 10054933
EUCTR2004-002312-29-FIINO Therapeutics800
Active, not recruiting
Not Applicable
The Effects of Nitric Oxide for Inhalation on the development of chronic lung disease in pre-term infants. - INOT-27
EUCTR2004-002312-29-ESINO Therapeutics600
Active, not recruiting
Not Applicable
The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term InfantsPrevention of chronic lung disease in pre-term infants gestational age 29 weeks with respiratory distress.MedDRA version: 9.1Level: LLTClassification code 10028974Term: Neonatal respiratory distress syndrome
EUCTR2004-002312-29-ITINO THERAPEUTICS