Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of North Carolina, Chapel Hill
With
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
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.
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Pharmacokinetics of Sildenafil in Premature Infants
