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

This study has been withdrawn prior to enrollment.
(No patients recruited)
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00981591
First received: September 18, 2009
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to wean off iNO. [ Time Frame: When the participant is successfully weaned off study drug ] [ Designated as safety issue: No ]
  • Time to extubation. [ Time Frame: When the participant is successfully weaned off study drug ] [ Designated as safety issue: No ]
  • Total cost of iNO. [ Time Frame: When the participant is successfully weaned off study drug ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to ICU discharge [ Time Frame: When the participant is successfully weaned off study drug. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981591

Sponsors and Collaborators
Seattle Children's Hospital
Actelion
Investigators
Principal Investigator: Delphine Yung, MD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00981591     History of Changes
Other Study ID Numbers: SCIL-001-12806
Study First Received: September 18, 2009
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Children's Hospital:
Iloprost
Nitric oxide
Mechanical ventilator

Additional relevant MeSH terms:
Acute Lung Injury
Heart Defects, Congenital
Hypertension
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiration Disorders
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Nitric Oxide
Anti-Asthmatic Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Hematologic Agents

ClinicalTrials.gov processed this record on November 25, 2014