CompletedPhase 3

A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

United States, Belgium, Canada59 participantsStarted 2013-08-05

Plain-language summary

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

Who can participate

Age range

0 Days – 4 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: * Neonates with persistent pulmonary hypertension of the newborn * Age \<=96 hours and \>=34 weeks gestational age * Oxygenation Index \>15 and \<60 * Concurrent treatment with inhaled nitric oxide and \>=50% oxygen Exclusion Criteria: * Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation * Expected duration of mechanical ventilation \<48 hours * Profound hypoxemia * Life-threatening or lethal congenital anomaly

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

Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Treatment Failure Rate

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Trial details

NCT IDNCT01720524

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-17

Results submitted2019-10-16

View on ClinicalTrials.gov More Pulmonary Hypertension, Familial Persistent, of the Newborn trials

Who can participate

Age range

0 Days – 4 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.

What they're measuring

Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Treatment Failure Rate

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)