Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients

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: NCT00981591
Recruitment Status : Withdrawn (No patients recruited)
First Posted : September 22, 2009
Last Update Posted : January 19, 2015
Information provided by (Responsible Party):
Delphine Yung, Seattle Children's Hospital

Brief Summary:
The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Neonatal Hypoxic Respiratory Failure Persistent Pulmonary Hypertension of Newborn Congenital Heart Defects Acute Respiratory Distress Syndrome Drug: Iloprost Drug: Placebo Phase 1 Phase 2

Detailed Description:
Inhaled nitric oxide (NO) is used in the management of all causes of pediatric pulmonary hypertension. Despite widespread use of nitric oxide to treat critically ill mechanically-ventilated pediatric patients with pulmonary hypertension, response to therapy is not universal. Nitric oxide fails to improve oxygenation in approximately 30% of these patients. Nonresponders to nitric oxide have few treatment options. Iloprost is the only other medication approved for inhalational delivery in the treatment of pulmonary hypertension. Inhalation therapy for pulmonary vasodilatation in critically ill children is inherently more attractive than oral or intravenous therapies due to the ability to deliver medication directly to the lung and to decrease systemic effects. The use of inhaled iloprost has been reported to decrease pulmonary vascular resistance in many pediatric pathologic settings, including combination therapy with nitric oxide.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Pilot Study of the Safety and Effective Dosing of Inhaled Iloprost in Pediatric Patients With Pulmonary Hypertension Treated With Inhaled Nitric Oxide
Study Start Date : September 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: Inhaled Iloprost Drug: Iloprost
Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes
Other Name: Ventavis

Placebo Comparator: Inhaled Placebo Drug: Placebo
Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more

Primary Outcome Measures :
  1. To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension. [ Time Frame: For the duration of time that the subject is receiving the study drug ]

Secondary Outcome Measures :
  1. Time to wean off iNO. [ Time Frame: When the participant is successfully weaned off study drug ]
  2. Time to extubation. [ Time Frame: When the participant is successfully weaned off study drug ]
  3. Total cost of iNO. [ Time Frame: When the participant is successfully weaned off study drug ]
  4. Incidence of rebound phenomenon, as defined by the need to return to a higher iNO dose after a previous wean. [ Time Frame: When the participant is successfully weaned off study drug ]
  5. Time to ICU discharge [ Time Frame: When the participant is successfully weaned off study drug. ]

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Birth to 21 years of age
  • Diagnosis of pulmonary hypertension must fit into one of three categories

    • neonatal hypoxic respiratory failure
    • congenital heart disease
    • acquired/acute respiratory distress syndrome (lung disease)
  • Parents of subject must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information
  • Patients who remain on nitric oxide at 12 to 18 hours after initiation
  • Patients who are transferred to an intensive care unit already on inhaled nitric oxide from another institution will be treated as if nitric oxide therapy was started at the time of admission to the unit
  • Patients will be enrolled only after a clinical decision to treat with nitric oxide has been made by the treating physician

Exclusion Criteria:

  • Corrected gestational age less than 35 weeks
  • Patients with potentially fatal non-cardiopulmonary co-morbidities (e.g. hepatic, neurologic, renal)
  • Known or suspected fatal genetic syndrome
  • Patient with cardiac failure secondary to significant left-sided obstructive lesions
  • Patient on ECMO
  • Patient on any other form of prostacyclin
  • Patient on any medication with known NO production, e.g., nitroprusside
  • Patient on an endothelin receptor antagonist (e.g. bosentan)
  • Patient on sildenafil
  • Patient on whom clinicians do not agree to follow standard inhaled nitric oxide weaning protocol
  • Patients who have known hypersensitivity to prostacyclin or any of its components
  • Patient who is pregnant
  • Patient with platelet count less than 50,000

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00981591

Sponsors and Collaborators
Seattle Children's Hospital
Principal Investigator: Delphine Yung, MD Seattle Children's Hospital

Responsible Party: Delphine Yung, Investigator, Seattle Children's Hospital Identifier: NCT00981591     History of Changes
Other Study ID Numbers: SCIL-001-12806
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015

Keywords provided by Delphine Yung, Seattle Children's Hospital:
Nitric oxide
Mechanical ventilator

Additional relevant MeSH terms:
Hypertension, Pulmonary
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Heart Defects, Congenital
Persistent Fetal Circulation Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
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