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
PHASE1
34 participants
INTERVENTIONAL
2013-02-28
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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sildenafil, standard of care
Infants receiving sildenafil as standard of care
No interventions assigned to this group
sildenafil administered for study
1 dose of sildenafil administered for study
1 dose of sildenafil
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.
Interventions
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1 dose of sildenafil
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
364 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
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Riley Hospital
Indianapolis, Indiana, United States
Kosair Pediatric Research Unit
Louisville, Kentucky, United States
Albany Medical Center
Albany, New York, United States
Kings County Hospital Center/SUNY Downstate Medical Center
Brooklyn, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Jackson W, Gonzalez D, Smith PB, Ambalavanan N, Atz AM, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Ahlfeld SK, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP, Laughon MM; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Safety of sildenafil in extremely premature infants: a phase I trial. J Perinatol. 2022 Jan;42(1):31-36. doi: 10.1038/s41372-021-01261-w. Epub 2021 Nov 5.
Other Identifiers
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HHSN27500014
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
11-1646
Identifier Type: -
Identifier Source: org_study_id