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Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

Testing sildenafil's safety for premature babies with lung issues.

Recruiting
29 years and younger
All
Phase 2

Study Overview: This study is testing the safety of a drug called sildenafil in premature babies with a lung condition known as severe bronchopulmonary dysplasia (BPD). BPD is a lung problem that affects infants, especially those who were born too early. This research involves comparing sildenafil to a placebo (a harmless pill that doesn't have any effect) in babies in Neonatal Intensive Care Units (NICUs).

  • The study lasts for up to 28 days, with a follow-up period of 28 days after stopping the study drug.
  • Participants will have regular medical checks, including heart and breathing tests.
  • Adverse effects will be monitored closely throughout the study.

Eligibility: Babies who were born before 29 weeks and are receiving breathing help may qualify. Parents must give consent for their baby to participate. Babies can't join if they've taken sildenafil or certain other medications recently or have certain heart or liver conditions.

Considerations: The study requires consent from a parent or guardian, involves frequent health checks, and monitors any potential side effects closely. Participants receive no direct benefits, but the study aims to help improve future treatments for BPD.

Study details
    Bronchopulmonary Dysplasia of Newborn

NCT04447989

Christoph Hornik

13 December 2024

Step 1 Get in touch with the nearest study center
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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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