Pharmacokinetics of Sildenafil in Premature Infants
| Status: | Recruiting | 
|---|---|
| Conditions: | High Blood Pressure (Hypertension) | 
| Therapuetic Areas: | Cardiology / Vascular Diseases | 
| Healthy: | No | 
| Age Range: | Any | 
| Updated: | 7/16/2016 | 
| Start Date: | February 2013 | 
| End Date: | August 2016 | 
| Contact: | Matthew M Laughon, MD, MPH | 
| Email: | matt_laughon@med.unc.edu | 
| Phone: | 984-974-5063 | 
The purpose of this study is to learn more about the safety and dosing of sildenafil in
infants.
			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.
receiving sildenafil per standard of care or 1 dose prescribed for the study.
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
We found this trial at
    9
    sites
	
								Durham, North Carolina 27710			
	
			(919) 684-8111 
							
					Principal Investigator: C. Michael Cotten, MD
			
						
								
		Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...  
  
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									1720 2nd Ave S
Birmingham, Alabama 35233
	
			Birmingham, Alabama 35233
(205) 934-4011  
							
					Principal Investigator: Ambalavanan Namasivayam, MD
			
						
								
		University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...  
  
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									3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
	
			Cincinnati, Ohio 45229
 1-513-636-4200  
							
					Principal Investigator: Brenda Poindexter, MD
			
						
								
		Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...  
  
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								Brooklyn, New York 11203			
	
			
					Principal Investigator: Gratias T Mundakel, MD
			
						
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								Chapel Hill, North Carolina 27599			
	
			(919) 962-2211 
							
					Principal Investigator: Sigal Peter-Wohl, MD
			
						
								
		Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...  
  
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									171 Ashley Avenue
Charleston, South Carolina 29425
	
			Charleston, South Carolina 29425
843-792-1414 
							
					Principal Investigator: Andrew Atz, MD
			
						
								
		Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...  
  
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