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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
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
Time to wean off iNO.
Time frame: When the participant is successfully weaned off study drug
Time to extubation.
Time frame: When the participant is successfully weaned off study drug
Total cost of iNO.
Time frame: When the participant is successfully weaned off study drug
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
Time to ICU discharge
Time frame: When the participant is successfully weaned off study drug.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.