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WithdrawnNCT00981591Updated Jan 19, 2015

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

A Phase 1/2 interventional study of Iloprost and Placebo in Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure and Persistent Pulmonary Hypertension of Newborn, sponsored by Seattle Children's Hospital. Withdrawn. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2015-01-19.

Sponsored by Seattle Children's Hospital · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
No patients recruited
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
Up to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pulmonary Hypertension
  • Neonatal Hypoxic Respiratory Failure
  • Persistent Pulmonary Hypertension of Newborn
  • Congenital Heart Defects
  • Acute Respiratory Distress Syndrome

Keywords

  • Iloprost
  • Nitric oxide
  • Mechanical ventilator
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Inhaled Iloprost

    Drug: Iloprost

  • Placebo comparator
    Inhaled Placebo

    Drug: Placebo

Interventions

  • DrugIloprost

    Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes

    Also known as: Ventavis

  • DrugPlacebo

    Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more

06

What researchers measure

Primary outcomes

  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 outcomes

  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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00981591
Lead sponsor
Seattle Children's Hospital
Collaborators
Actelion
Responsible party
Delphine Yung (Investigator, Seattle Children's Hospital) — Principal investigator
First posted
Sep 22, 2009
Start date
Sep 2009
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Jan 19, 2015

Study contacts

Delphine Yung, MD
principal investigator · Seattle Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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