Trial · NCT04447989
Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
NCT04447989, Phase 2, Completed, Christoph Hornik; results first posted 2026-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia. Trials, record NCT04447989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04447989
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
- NCT number
- NCT04447989
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Christoph Hornik
- Conditions
- Bronchopulmonary Dysplasia of Newborn
- Interventions
- Sildenafil, Placebo
- First posted
- 2020-06-25
- Last updated
- 2026-01-26
- Results first posted
- 2026-01-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Based Upon Number of Participants With Hypotension | 28 days post last dose of study drug, up to 9 weeks | Safety as determined by incidence of hypotension experienced by the participants through 28 days post last dose of study drug. Hypotension will be defined as any clinically significant low blood pressure event deemed by the treating physician to require intervention with a fluid bolus or the initiation or escalation of inotropic, vasopressor, or systemic steroid therapy with the specific intent to raise blood pressure. |
| Secondary | Central Volume of Distribution (Vc) Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | |
| Secondary | Peripheral Volume of Distribution (Vp) Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | |
| Secondary | Clearance Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | |
| Secondary | Half-life Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | |
| Secondary | Peak Plasma Concentration Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | |
| Other | Number of Participants at Each Global Rank | 28 days post last dose of study drug, up to 9 weeks | Global rank is defined as clinically significant events ranked in order of decreasing perceived severity. Rank descriptions are presented from most to least severe. |
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 Based Upon Number of Participants With Hypotension | 28 days post last dose of study drug, up to 9 weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Central Volume of Distribution (Vc) Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | Population Pharmacokinetics (popPK) analysis does not involve separating PK parameters by dose group. All samples across all dose groups are analyzed together. | L | MEDIAN |
| SECONDARY | Peripheral Volume of Distribution (Vp) Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | Population Pharmacokinetics (popPK) analysis does not involve separating PK parameters by dose group. All samples across all dose groups are analyzed together. | L | MEDIAN |
| SECONDARY | Clearance Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | Population Pharmacokinetics (popPK) analysis does not involve separating PK parameters by dose group. All samples across all dose groups are analyzed together. | L/h | MEDIAN |
| SECONDARY | Half-life Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | Population Pharmacokinetics (popPK) analysis does not involve separating PK parameters by dose group. All samples across all dose groups are analyzed together. | hours | MEDIAN |
| SECONDARY | Peak Plasma Concentration Population Pharmacokinetics (popPK) | Following the completion of 7 days (168 hours) of study drug administration | Population Pharmacokinetics (popPK) analysis does not involve separating PK parameters by dose group. All samples across all dose groups are analyzed together. | ng/mL | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants at Each Global Rank | 28 days post last dose of study drug, up to 9 weeks | Intent to treat (ITT) population with a global rank available. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group85
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Based Upon Number of Participants With Hypotension | Cohort 1, Sildenafil | 1 | Participants | ||
| Safety Based Upon Number of Participants With Hypotension | Cohort 2, Sildenafil | 0 | Participants | ||
| Safety Based Upon Number of Participants With Hypotension | Cohort 3, Sildenafil | 0 | Participants | ||
| Safety Based Upon Number of Participants With Hypotension | Placebo | 0 | Participants | ||
| Central Volume of Distribution (Vc) Population Pharmacokinetics (popPK) | Pharmacokinetics (PK) Cohort | 3.86 | 95% Confidence Interval 1.28 to 11.07 | L | |
| Peripheral Volume of Distribution (Vp) Population Pharmacokinetics (popPK) | Pharmacokinetics (PK) Cohort | 4.49 | 95% Confidence Interval 2.87 to 6.66 | L | |
| Clearance Population Pharmacokinetics (popPK) | Pharmacokinetics (PK) Cohort | 2.69 | 95% Confidence Interval 1.00 to 7.94 | L/h | |
| Half-life Population Pharmacokinetics (popPK) | Pharmacokinetics (PK) Cohort | 8.79 | Inter-Quartile Range 8.00 to 9.42 | hours | |
| Peak Plasma Concentration Population Pharmacokinetics (popPK) | Pharmacokinetics (PK) Cohort | 130.5 | Inter-Quartile Range 70.9 to 256.0 | ng/mL | |
| Number of Participants at Each Global Rank | Cohort 1, Sildenafil | Mortality | 0 | Participants |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1, Sildenafil | 32 | |
| Overall Study | STARTED | Cohort 2, Sildenafil | 30 | |
| Overall Study | STARTED | Cohort 3, Sildenafil | 32 | |
| Overall Study | STARTED | Placebo | 31 | |
| Overall Study | COMPLETED | Cohort 1, Sildenafil | 31 | |
| Overall Study | COMPLETED | Cohort 2, Sildenafil | 27 | |
| Overall Study | COMPLETED | Cohort 3, Sildenafil | 31 | |
| Overall Study | COMPLETED | Placebo | 26 | |
| Overall Study | NOT COMPLETED | Cohort 1, Sildenafil | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2, Sildenafil | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events52
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 |
|---|---|---|---|---|---|---|
| serious | Retinopathy of prematurity | Eye disorders | Cohort 1, Sildenafil | 2 | 31 | |
| serious | Retinopathy of prematurity | Eye disorders | Cohort 2, Sildenafil | 0 | 29 | |
| serious | Retinopathy of prematurity | Eye disorders | Cohort 3, Sildenafil | 0 | 32 | |
| serious | Retinopathy of prematurity | Eye disorders | Placebo | 1 | 30 | |
| serious | Pneumonia bacterial | Infections and infestations | Cohort 1, Sildenafil | 0 | 31 | |
| serious | Pneumonia bacterial | Infections and infestations | Cohort 2, Sildenafil | 0 | 29 | |
| serious | Pneumonia bacterial | Infections and infestations | Cohort 3, Sildenafil | 1 | 32 | |
| serious | Pneumonia bacterial | Infections and infestations | Placebo | 0 | 30 | |
| serious | Sepsis | Infections and infestations | Cohort 1, Sildenafil | 0 | 31 | |
| serious | Sepsis | Infections and infestations | Cohort 2, Sildenafil | 0 | 29 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1, Sildenafil | 0 | 31 |
| Total, all-cause mortality | Cohort 2, Sildenafil | 2 | 29 |
| Total, all-cause mortality | Cohort 3, Sildenafil | 1 | 32 |
| Total, all-cause mortality | Placebo | 0 | 30 |
| Total, other adverse events | Cohort 1, Sildenafil | 0 | 0 |
| Total, other adverse events | Cohort 2, Sildenafil | 0 | 0 |
| Total, other adverse events | Cohort 3, Sildenafil | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | Cohort 1, Sildenafil | 3 | 31 |
| Total, serious adverse events | Cohort 2, Sildenafil | 0 | 29 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers12
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| R61HL147833 | Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia | HORNIK, CHRISTOPH; LAUGHON, MATTHEW | DUKE UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2019 to 2020 |
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/NCT04447989
GET https://conductscience.org/api/trials/v1/NCT04447989/results?page=2