Persistent Pulmonary Hypertension of the Newborn (NCT01389856) | Clinical Trial Compass
TerminatedPhase 3
Persistent Pulmonary Hypertension of the Newborn
Stopped: To be compliant with the timelines as agreed with Paediatric Committee (PC) within the Paediatric Investigational Plan
23 participantsStarted 2011-12
Plain-language summary
The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.
Who can participate
Age range12 Hours – 7 Days
SexALL
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Inclusion criteria
✓. Signed informed consent by the parent(s) or the legal representative(s).
✓. Term and near term newborns (gestational age \> 34 weeks).
✓. Post natal age ≥ 12 hours and \< 7 days.
✓. Weight at birth ≥ 2,000 g.
✓. Idiopathic PPHN or PPHN due to parenchymal lung disease
✓. Documented diagnosis of pulmonary hypertension (PH) confirmed by echocardiography.
✓. Need for continued inhaled nitric oxide (iNO) at a dose \> 10ppm after at least 4 hours of continuous iNO treatment.
✓. Two oxygenation index (OI) values ≥ 12 taken at least 30 minutes apart, in the 12 hours prior to randomization and while the patient is receiving iNO treatment.
Exclusion criteria
✕. PH associated with conditions other than PPHN.
✕. Immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ECMO).
✕. Lethal congenital anomalies.
✕. Congenital Diaphragmatic Hernia.
✕. Significant structural cardiac anomalies.
✕
What they're measuring
1
Percentage of Patients With Treatment Failure
Timeframe: From baseline to up to 21 days
2
Time to Complete Weaning From iNO
Timeframe: From baseline to up to 21 days
3
Time to Complete Weaning From Mechanical Ventilation