Trial · NCT03142568
Safety of Sildenafil in Premature Infants
NCT03142568, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2026-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of Sildenafil in Premature Infants. Trials, record NCT03142568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03142568
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Sildenafil in Premature Infants
- NCT number
- NCT03142568
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Sildenafil, Placebo
- First posted
- 2017-05-05
- Last updated
- 2026-03-30
- Results first posted
- 2026-03-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety as Determined by Adverse Event Experienced by Participants | Nonserious AEs were collected through Day 14 post last intervention; SAEs through Day 28. Retinopathy of prematurity was assessed through discharge/transfer, up to 575 days after first treatment. | Description of safety of sildenafil in premature infants and assessed by frequency and incidence of adverse events (AEs) and serious adverse events. Both non-serious and serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days. |
| Secondary | Volume of Distribution | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | Volume of distribution was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment. |
| Secondary | Clearance | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | Clearance was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment. |
| Secondary | Half-Life | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | Half-life was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment. |
| Secondary | Area Under the Curve (AUC) | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | Exposure, as measured by area under the plasma concentration-time curve (AUC), was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment. |
| Secondary | Peak Plasma Concentration | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | Maximum plasma concentration (Cmax) was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment. |
| Secondary | Change in Moderate-severe BPD or Death | From the first day of study drug administration to the end of study drug administration, up to 28 days | Moderate-severe bronchopulmonary dysplasia (BPD) or death risk will be defined by the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) BPD outcome estimator. https://neonatal.rti.org/. The outcome measure is a reduction in moderate-severe BPD or death risk from day 1 of study drug to end of study drug administration. The BPD outcome estimator uses the following to calculate risk of BPD: Gestational age, Birth weight, Sex, Maternal Race/EthnicitylmPostnatal day, Ventilation type, Fraction of Inspired Oxygen The NICHD NRN BPD estimator calculates the risk of BPD (none, mild, moderate, severe) or death by postnatal day, as a percentage. For this protocol, outcomes will be dichotomized as none-mild vs. moderate-severe-death. Risk estimates will be recorded on days 7, 14, 21, and 28 of the study drug period, using the day closest to the participants postnatal age. For infants older than 28 days, the day 28 estimate will be applied. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety as Determined by Adverse Event Experienced by Participants | Nonserious adverse events were collected through Day 14 following last study intervention. Serious adverse events were collected through Day 28 following last study intervention. Retinopathy of prematurity was assessed through hospital discharge/transfer. | Outcome measures are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while outcome analyses follow the protocol-defined grouping. | Events | NUMBER |
| SECONDARY | Volume of Distribution | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate volume of distribution. Pharmacokinetic outcomes only assessed in participants who received active study drug. | L/kg | MEDIAN |
| SECONDARY | Clearance | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate clearance. Pharmacokinetic outcomes only assessed in participants who received active study drug. | L/h/kg | MEDIAN |
| SECONDARY | Half-Life | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate half-life. Pharmacokinetic outcomes only assessed in participants who received active study drug. | hours | MEDIAN |
| SECONDARY | Area Under the Curve (AUC) | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate area under the curve. Pharmacokinetic outcomes only assessed in participants who received active study drug. | ng*h/mL | MEDIAN |
| SECONDARY | Peak Plasma Concentration | Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration. | The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate peak plasma concentration. Pharmacokinetic outcomes only assessed in participants who received active study drug. | ng/mL | MEDIAN |
| SECONDARY | Change in Moderate-severe BPD or Death | From the first day of study drug administration to the end of study drug administration, up to 28 days | The number of participants analyzed at each study week may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits, early termination, and/or missing data elements.~Participants in Sildenafil Cohort 1 did not undergo a weaning period due to the low sildenafil doses administered and the minimal risk of rebound effects. No data were collected or analyzed for this outcome in Cohort 1. | Percent probability of risk BPD or death | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety as Determined by Adverse Event Experienced by Participants | Sildenafil Cohort 1 | 71 | Events | ||
| Safety as Determined by Adverse Event Experienced by Participants | Sildenafil Cohort 2 | 83 | Events | ||
| Safety as Determined by Adverse Event Experienced by Participants | Sildenafil Cohort 3 | 53 | Events | ||
| Safety as Determined by Adverse Event Experienced by Participants | Placebo Total | 60 | Events | ||
| Volume of Distribution | Sildenafil Cohort 1 | 3.01 | Full Range 1.78 to 17.25 | L/kg | |
| Volume of Distribution | Sildenafil Cohort 2 | 3.67 | Full Range 1.62 to 24.52 | L/kg | |
| Volume of Distribution | Sildenafil Cohort 3 | 3.07 | Full Range 1.71 to 8.78 | L/kg | |
| Clearance | Sildenafil Cohort 1 | 1.23 | Full Range 0.46 to 4.24 | L/h/kg | |
| Clearance | Sildenafil Cohort 2 | 1.54 | Full Range 0.46 to 4.20 | L/h/kg | |
| Clearance | Sildenafil Cohort 3 | 1.30 | Full Range 0.41 to 6.73 | L/h/kg |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sildenafil Cohort 1 | 30 | |
| Overall Study | STARTED | Placebo Cohort 1 | 10 | |
| Overall Study | STARTED | Sildenafil Cohort 2 | 33 | |
| Overall Study | STARTED | Placebo Cohort 2 | 10 | |
| Overall Study | STARTED | Sildenafil Cohort 3 | 17 | |
| Overall Study | STARTED | Placebo Cohort 3 | 6 | |
| Overall Study | Received Intervention | Sildenafil Cohort 1 | 30 | |
| Overall Study | Received Intervention | Placebo Cohort 1 | 10 | |
| Overall Study | Received Intervention | Sildenafil Cohort 2 | 30 | |
| Overall Study | Received Intervention | Placebo Cohort 2 | 10 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events424
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil Cohort 1 | 3 | 30 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil Cohort 2 | 0 | 30 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil Cohort 3 | 1 | 16 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Total | 3 | 26 | 3 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Sildenafil Cohort 1 | 1 | 30 | 1 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Sildenafil Cohort 2 | 2 | 30 | 2 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Sildenafil Cohort 3 | 2 | 16 | 2 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Placebo Total | 0 | 26 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Sildenafil Cohort 1 | 0 | 30 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Sildenafil Cohort 2 | 1 | 30 | 1 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sildenafil Cohort 1 | 1 | 30 |
| Total, all-cause mortality | Sildenafil Cohort 2 | 1 | 30 |
| Total, all-cause mortality | Sildenafil Cohort 3 | 2 | 16 |
| Total, all-cause mortality | Placebo Total | 1 | 26 |
| Total, other adverse events | Sildenafil Cohort 1 | 27 | 30 |
| Total, other adverse events | Sildenafil Cohort 2 | 27 | 30 |
| Total, other adverse events | Sildenafil Cohort 3 | 14 | 16 |
| Total, other adverse events | Placebo Total | 21 | 26 |
| Total, serious adverse events | Sildenafil Cohort 1 | 3 | 30 |
| Total, serious adverse events | Sildenafil Cohort 2 | 8 | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD006099 | Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia | LAUGHON, MATTHEW | UNIV OF NORTH CAROLINA CHAPEL HILL | FOOD AND DRUG ADMINISTRATION | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03142568
GET https://conductscience.org/api/trials/v1/NCT03142568/results?page=2