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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN27500014 | Other Grant/Funding Number | NICHD |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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The purpose of this study is to learn more about the safety and dosing of sildenafil in 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sildenafil, standard of care | No Intervention | Infants receiving sildenafil as standard of care | |
| sildenafil administered for study | Other | 1 dose of sildenafil administered for study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 dose of sildenafil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve 0-24 hours for sildenafil | IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose | |
| Peak plasma concentration of sildenafil | IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose | |
| Clearance of sildenafil | IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose | |
| Volume of distribution at steady state | IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose | |
| Half life of sildenafil | IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability. | From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of sildenafil to 7 days after the last dose of sildenafil | |
| Correlation between serum and dried blood spot samples |
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Inclusion Criteria:
Cohort 1:
Cohort 2:
Exclusion Criteria:
Cohort 1:
Cohort 2:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew M Laughon, MD, MPH | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249-7335 | United States | ||
| Riley Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34741102 | Derived | 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. |
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| ID | Term |
|---|---|
| D010547 | Persistent Fetal Circulation Syndrome |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
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| 1-7 days |
| Evaluate P450 single nucleotide polymorphisms (SNPs) | 2-7 days |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Kosair Pediatric Research Unit | Louisville | Kentucky | 40202 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Kings County Hospital Center/SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |