Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants - Full Text View

Purpose

This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.

Condition	Intervention	Phase
Bronchopulmonary Dysplasia	Drug: Inhaled Nitric Oxide Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth

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:

Survival without BPD at 36 weeks [ Time Frame: Baseline, 36 weeks PMA ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Vital Signs [ Time Frame: Study duration ] [ Designated as safety issue: No ]
Need for respiratory support [ Time Frame: Study duration up to discharge ] [ Designated as safety issue: No ]
air pressure support, oxygen
Adverse Events [ Time Frame: During study drug administration only ] [ Designated as safety issue: Yes ]
AEs will include intracranial hemorrhage; patent ductus requiring intervention; necrotizing enterocolitis; intestinal perforations; airs leaks of any type; pulmonary hemorrhage, retinopathy of prematurity; sepsis
Incidence of methemoglobinemia [ Time Frame: Baseline, 24, 48 and 72 hours ] [ Designated as safety issue: Yes ]
Includes elevated nitrogen dioxide concentrations

Estimated Enrollment:	450
Study Start Date:	November 2009
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Inhaled Nitric Oxide Inhaled Nitric Oxide	Drug: Inhaled Nitric Oxide Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
Placebo Comparator: Placebo Nitrogen Placebo	Drug: Placebo Nitrogen gas will be administered in the same manner as the experimental drug.

Detailed Description:

Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks GA using a physiologic assessment of BPD.

Eligibility

Ages Eligible for Study:	up to 14 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Preterm infants who are:
1. 500 to 1250 grams at birth
2. < 30 weeks gestational age
3. 5 to 14 days of age (inclusive) at the time of entry
4. Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)

Exclusion Criteria:

Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care
Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
Subjects who are dependent on right to left shunting to maintain the systemic circulation
Preterm infants who received prior iNO therapy
Use of another investigational agent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931632

Show 33 Study Locations

Sponsors and Collaborators

INO Therapeutics

Investigators

Study Director:

James Baldassarre, MD

INO Therapeutics

More Information

No publications provided

Responsible Party:	INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00931632 History of Changes
Other Study ID Numbers:	IK-3001-BPD-301
Study First Received:	July 1, 2009
Last Updated:	April 30, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by INO Therapeutics:

Bronchopulmonary Dysplasia, BPD

Additional relevant MeSH terms:

Bronchopulmonary Dysplasia
Hyperplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pathologic Processes
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013