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 range
12 Hours – 7 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Medically significant pneumothorax.
. Active seizures.
. Expected duration of mechanical ventilation of less than 48 hours.