Completed

Pharmacokinetics of Sildenafil in Premature Infants

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What is being tested

1 dose of sildenafil

Drug
Who is being recruted

Hypertension, Pulmonary+3

+ Infant, Newborn, Diseases

+ Lung Diseases

See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: November 2, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01670136
Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: November 2, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

34 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hypertension, PulmonaryInfant, Newborn, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiratory Tract DiseasesPersistent Fetal Circulation Syndrome

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Infants receiving sildenafil as standard of care

Group II

1 dose of sildenafil administered for study

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps

Riley Hospital

Indianapolis, United States

Kosair Pediatric Research Unit

Louisville, United States

Albany Medical Center

Albany, United States
Completed9 Study Centers