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

Sponsored by:	INO Therapeutics
Information provided by:	INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00551642

Purpose

The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.

Condition	Intervention	Phase
Lung Disease	Drug: Nitric Oxide for inhalation Drug: Nitrogen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-Term Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by INO Therapeutics:

Primary Outcome Measures:

Chronic Lung Disease [ Time Frame: 36 weeks GA ] [ Designated as safety issue: No ]
Survival [ Time Frame: 36 Weeks GA ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vital Signs [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
Arterial Oxygen Saturation by Pulse Oximetry [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
Methemoglobin Level [ Time Frame: Baseline, then 24 hours, 2-6 days, Day 7 and Day 14 of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	May 2005
Estimated Study Completion Date:	March 2015
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A 24+0-25+6 days weeks gestational age	Drug: Nitric Oxide for inhalation inhaled nitric oxide given at 5ppm for 7-21 days Drug: Nitrogen nitrogen gas given at 5ppm for 7-21 days
Group B 26+0 - 28+6 days weeks Gestational Age	Drug: Nitric Oxide for inhalation inhaled nitric oxide given at 5ppm for 7-21 days Drug: Nitrogen nitrogen gas given at 5ppm for 7-21 days

Detailed Description:

Although the effects of inhaled NO on pulmonary vascular tone are well-described and relevant to term infants with persistent pulmonary hypertension, the pathophysiology of respiratory failure in preterm infants may be quite different. Chronic lung disease (CLD) represents the final pathway of a heterogeneous group of pulmonary disorders of infancy that usually start in the neonatal period. CLD most commonly occurs in preterm (<30 weeks of gestational age (GA) infants with birth weights less than 1,500 g, and especially in those very preterm (<26 wks GA) with birth weights less than 1,000 g, and who have been treated for respiratory distress syndrome (RDS).

Eligibility

Ages Eligible for Study:	up to 26 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 CPAP (FiO2 ≥ 0.30 on a mean airway pressure ≥ 4cm H2O) within 24 hours of birth in order to maintain an 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 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/mm³, fibrinogen <0.5 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551642

Show 35 Study Locations

Sponsors and Collaborators

INO Therapeutics

Investigators

Study Chair:

Jean-Christophe Mercier

Hospital Robert Debre

More Information

No publications provided

Responsible Party:	INO Therapeutics ( James Baldassarre, MD )
Study ID Numbers:	INOT27, EUNO, EU Preemie
Study First Received:	October 30, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00551642 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by INO Therapeutics:

Preemie, Inhaled Nitric Oxide

Study placed in the following topic categories:

Nitric Oxide
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Respiratory Tract Diseases

Lung Diseases
Anti-Asthmatic Agents
Cardiovascular Agents
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions

Nitric Oxide
Respiratory Tract Diseases
Autonomic Agents
Lung Diseases
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on July 02, 2009