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

Sponsor:	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

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Locations

Belgium
UCL St. LUC
Bruxelles, Belgium
Clinique Notre Dame
Charleroi, Belgium
Clinique St. Vincent CHC
Rocourt, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Finland
Oulun yliopsistollinen sairaala
Oulu, Finland, FI-90220
France
Centre Hospitalier Intercommunal de Creteil
Creteil, France, 94000
Hospital Robert Debre
Paris, France, 75019
Hospital Mere-Enfant
Nantes Cedex 1, France, 44093
Germany
Universitaeklinikum Tuebingen
Tuebingen, Germany, 72076
Univeritaetsklinik Ulm
Ulm, Germany, 89075
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69115
Universitaetsklinikum Marburg
Marburg, Germany, 35033
Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Universitaetsklinikum Muenchen
Muenchen, Germany, 81377
Campus Charite Mitte
Berlin, Germany, 10117
Italy
Az. Osp. G. Salesi
Ancona, Italy, 60123
University Padova
Padova, Italy, 35128
Ospedali Riuniti
Bergamo, Italy, 24128
Azienda Ospedaliera Careggi
Firenze, Italy, 50134
Policlinico S. Orsola
Bologna, Italy, 40138
Policlinico Gemelli
Roma, Italy, 00168
Netherlands
Sophia Kinderziekenhuis
Rotterdam, Netherlands, 3000 CB
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Spain
Hospital Universitario Canarias
Santa Cruz de Tenerife, Spain, 38320
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitario La Fe
Valencia, Spain, 46009
Hosspital Univeritario La Paz
Madrid, Spain, 28046
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario Gregorio Mar
Madrid, Spain, 28007
Hospital de Cruces
Barakaldo (Vizcaya), Spain, 48903
Sweden
Akademiska Sjukhuset
Uppsala, Sweden, SE-751 85
Astrid Lindgrens barnsjukjus, Karolinska Unviersritets sjukhuset-Solna
Stockholm, Sweden, SE-171 76
United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Kings College
London, United Kingdom, SE5 9RS
Meedway Mariton Hospital
Kent, United Kingdom, ME7 5NY

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

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 November 30, 2009