NCT01670136 - Pharmacokinetics of Sildenafil in Premature Infants | Crick

Overview

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

Pharmacokinetics and safety of sildenafil will be studied in preterm infants who are receiving sildenafil per standard of care or 1 dose prescribed for the study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

34

Conditions

Persistent Pulmonary Hypertension of the Newborn

Interventions

1 dose of sildenafilDRUG

A single IV dose of sildenafil will be administered over 90 minutes with no greater than a 15-minute flush. Final dose to be determined based on at least the first 4 participants enrolled in Cohort 1; final dose expected to be a single dose between 0.25 and 0.5 mg/kg.

Eligibility

Sex: ALLMax age: 364 Days

Medical Language ↔ Plain English

Inclusion Criteria: Cohort 1: * Gestational age 28 weeks or less receiving sildenafil as standard of care \< 365 postnatal days Cohort 2: * Gestational age 28 weeks or less * 7-28 postnatal days of age * Mechanical ventilation or nasal continuous positive airway pressure (NCPAP) or high-flow nasal cannula * Intravenous line in place Exclusion Criteria: Cohort 1: * Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study Cohort 2: * Previous exposure to sildenafil within 7 days prior to enrollment * Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study * History of allergic reactions to sildenafil * AST \> ULN or ALT \> 3x ULN * Currently on a vasopressor for hypotension * Known sickle cell disease

Locations (9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Riley Hospital

Indianapolis, Indiana, United States

Kosair Pediatric Research Unit

Louisville, Kentucky, United States