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Pharmacokinetics of Sildenafil in Premature Infants

ClinicalTrials.gov · COMPLETED, 2016

34 participants

Abstract

The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.

Conditions: Persistent Pulmonary Hypertension of the Newborn.

Primary outcome: Area under the plasma concentration versus time curve 0-24 hours for sildenafil; Peak plasma concentration of sildenafil; Clearance of sildenafil; Volume of distribution at steady state; Half life of sildenafil.

Enrollment: 34 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 34 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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