Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
239 participants
OBSERVATIONAL
2014-09-30
2015-10-31
Brief Summary
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A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was planned to be included.
The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management.
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Interventions
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Inhaled Nitric Oxide with monitoring by EZ-KINOX device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
1 Day
ALL
No
Sponsors
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Euraxi Pharma
INDUSTRY
Air Liquide Santé International
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe POUARD, MD
Role: STUDY_CHAIR
Hôpital Necker-Enfants Malades
Locations
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Cliniques Universitaires ST Luc
Brussels, , Belgium
CHU Sart TILMAN
Liège, , Belgium
Hôpital Pitié-Salpêtrière
Paris, Cedex 13, France
Hôpital Necker-Enfants Malades
Paris, Paris Cedex, France
Hôpital Haut-Lévèque
Bordeaux, , France
Hôpital du Bocage Central
Dijon, , France
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
CHU de Nantes - Hôpital Laennec
Nantes, , France
Hôpital Hôtel Dieu
Nantes, , France
Hôpital Trousseau
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
American Memorial Hospital
Reims, , France
Clinique Pasteur
Toulouse, , France
Countries
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References
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Pepke-Zaba J, Higenbottam TW, Dinh-Xuan AT, Stone D, Wallwork J. Inhaled nitric oxide as a cause of selective pulmonary vasodilatation in pulmonary hypertension. Lancet. 1991 Nov 9;338(8776):1173-4. doi: 10.1016/0140-6736(91)92033-x.
Gaudard P, Barbanti C, Rozec B, Mauriat P, M'rini M, Cambonie G, Liet JM, Girard C, Leger PL, Assaf Z, Damas P, Loron G, Lecourt L, Amour J, Pouard P. New Modalities for the Administration of Inhaled Nitric Oxide in Intensive Care Units After Cardiac Surgery or for Neonatal Indications: A Prospective Observational Study. Anesth Analg. 2018 Apr;126(4):1234-1240. doi: 10.1213/ANE.0000000000002813.
Other Identifiers
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ALMED-13-C4-046
Identifier Type: -
Identifier Source: org_study_id
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