Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2018-04-02
2025-01-03
Brief Summary
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Detailed Description
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This is a Phase II study design, premature infants (inpatient in neonatal intensive care units) will be randomized in a dose escalating approach 3:1 (sildenafil: placebo) into 3 cohorts with escalating doses of sildenafil. There will be 40 randomized and dosed participants in each cohort for a total of up to 120 participants. Cohort 1 sildenafil dose will be 0.125 mg/kg q 8 hours IV or 0.25 mg/kg q 8 hours enteral. Cohort 2 sildenafil dose will be 0.5 mg/kg q 8 hours IV or 1.0 mg/kg q 8 hours enteral. Cohort 3 sildenafil dose will be 1 mg/kg q 8 hours IV or 2 mg/kg q 8 hours enteral.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sildenafil cohort 1
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil
Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo cohort 1
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Placebo
Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Sildenafil cohort 2
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil
Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo cohort 2
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Placebo
Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Sildenafil cohort 3
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil
Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo cohort 3
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Placebo
Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Interventions
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Sildenafil
Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo
Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \<29 weeks gestational age at birth
* 7-28 (inclusive) days postnatal age at time of randomization
Exclusion Criteria
* Currently receiving inhaled nitric oxide
* Baseline mean arterial pressure \< gestational age (in weeks) plus postnatal age (in weeks) within 2 hours of sildenafil administration
* Known allergy to sildenafil
* Known sickle cell disease
* AST \> 225 U/L \< 72 hours prior to randomization
* ALT \> 150 U/L \< 72 hours prior to randomization
7 Days
28 Days
ALL
No
Sponsors
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Duke University
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The Emmes Company, LLC
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Matthew M Laughon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Florida College of Medicine Jacksonville-Wolfson Children's Hospital
Jacksonville, Florida, United States
University of Florida Jacksonville Shands Medical Center
Jacksonville, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Wesley Medical Center
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Hospital of Nevada at UMC
Las Vegas, Nevada, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Cohen Children's Medical Center of NY
New Hyde Park, New York, United States
Golisano Children's Hospital - University of Rochester Medical Center
Rochester, New York, United States
WakeMed Health and Hospitals
Raleigh, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Health Sciences Centre Hospital
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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75N94022F00001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
17-2436
Identifier Type: -
Identifier Source: org_study_id
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