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Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922532
Recruitment Status : Withdrawn (Company decision not to pursue prior to submission)
First Posted : June 17, 2009
Last Update Posted : September 9, 2016
Information provided by (Responsible Party):

Brief Summary:

This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants.

Study subjects will be administered either inhaled nitric oxide or placebo to determine if there is a change in oxygenation.

Condition or disease Intervention/treatment Phase
Hypoxic Respiratory Failure With Pulmonary Hypertension Drug: Inhaled Nitric Oxide Drug: Placebo Phase 3

Detailed Description:

This trial will be a multi-center, double blind, placebo-controlled, randomized clinical trial. All mothers identified with prolonged rupture of membranes and/or oligohydramnios, and all inborn infants < 30 weeks gestational age (GA) at birth will be screened for enrollment. Infants who meet all inclusion and exclusion criteria within the first 48 hours after birth will be randomized to either inhaled NO starting at 20 ppm, or matched placebo, delivered by means of a blinded INOvent® delivery device. Randomization will be stratified by center and treatment will be assigned using an interactive voice or web-based response system (IVRS). All infants will receive up to 14 days of therapy, following a dose reduction schedule. The primary outcome measure will be change in oxygenation at 1 hour after start of therapy. In order to determine the effects of iNO therapy on survival and need for mechanical ventilation, cross-over will not be allowed.

This clinical trial will attempt to demonstrate if pre-term infants may benefit from treatment with nitric oxide for inhalation. A multi-center study is necessary to recruit an appropriate number of subjects, and to reflect the variability of standard practice across the different participating centers. All treatment assignments are blinded in order to minimize the risk of bias in treatment and data collection. In addition, a concurrent placebo group has been chosen as the most appropriate control group since there may be temporal, institutional and national variations in average outcomes. Methemoglobin levels will be measured locally and will collected in a blinded manner.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Inhaled Nitric Oxide For The Treatment Of Hypoxic Respiratory Failure With Pulmonary Hypertension In Preterm Infants
Study Start Date : November 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Inhaled Nitric Oxide
Inhaled Nitric Oxide
Drug: Inhaled Nitric Oxide
Inhaled Nitric Oxide will be administered continuously starting at 20ppm through an INOvent delivery system for up to 14 days.
Other Name: INOmax

Placebo Comparator: Nitrogen
Nitrogen Placebo
Drug: Placebo
Nitrogen gas will be administered in the same manor as the experimental drug

Primary Outcome Measures :
  1. Arterial Blood Gases [ Time Frame: Day 1 through Day 6 ]

Secondary Outcome Measures :
  1. Methemoglobin levels [ Time Frame: Treatment Duration ]
  2. Vital Signs [ Time Frame: Study Duration ]
  3. Adverse Events [ Time Frame: Study Duration ]
  4. cGMP Levels [ Time Frame: Day 1 through 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Preterm infants who:

  • Are in-born at < 30 weeks gestational age
  • Weigh 500-1250 grams
  • Have hypoxic respiratory failure requiring mechanical ventilation with FiO2 > 0.8 to maintain SaO2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
  • Have minimal parenchymal lung disease by chest X ray

Exclusion Criteria:

Preterm infants who:

  • Have ten minute Apgar score < 5
  • Have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
  • Have bilateral Grade IV Intraventricular Hemorrhage (IVH)
  • Are dependent on right to left shunting to maintain the systemic circulation
  • Have received prior iNO therapy
  • Have had treatment with investigational medications

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Responsible Party: Mallinckrodt Identifier: NCT00922532     History of Changes
Other Study ID Numbers: IK-3001-HRF-301
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016

Keywords provided by Mallinckrodt:
Hypoxic Respiratory Failure (HRF), Pulmonary Hypertension

Additional relevant MeSH terms:
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Hypertension, Pulmonary
Respiratory Insufficiency
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents