Trial · NCT03701074
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
NCT03701074, Phase 2, Terminated, University of South Alabama; results first posted 2021-05-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus. Trials, record NCT03701074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03701074
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
- NCT number
- NCT03701074
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- University of South Alabama
- Conditions
- Patent Ductus Arteriosus, Preterm Infant, Bronchopulmonary Dysplasia
- Interventions
- Ibuprofen and acetaminophen, Ibuprofen and placebo
- First posted
- 2018-10-09
- Last updated
- 2026-04-30
- Results first posted
- 2021-05-11
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Ductus Arteriosus Closure/Constriction | 24-48 hours after the completion of study intervention | Ductal closure/constriction rate as defined based on the echocardiographic findings. Ductal closure/constriction will be defined as the complete closure of ductus or ductal diameter \<1 mm |
| Secondary | Echocardiographic Patent Ductus Arteriosus Parameters Before and After the Study Intervention | 24-48 hours after the completion of study intervention | Echocardiographic parameters including ductal size (PDA size in mm), Left atrium to aortic root ratio, ductal velocity, descending aortic diastolic flow, before and after the intervention. Between the group and within the group comparison |
| Secondary | Ventilatory Settings Before and After the Study Intervention | 24-48 hours after the completion of study intervention | Ventilator parameters including Fio2, Mean airway pressure, Peak Inspiratory pressure, PEEP, and ventilatory rate oxygenation indices including Oxygenation index and Respiratory Severity score before and after intervention |
| Secondary | Proportion of Participants With Liver Injury | 24-48 hours after the completion of study intervention | liver enzymes compared before and after the study intervention; if any significant elevation of liver enzymes from baseline, the participant classified as having liver injury |
| Secondary | Proportion of Participants With Renal Injury | 24-48 hours after the completion of study intervention | Blood urea nitrogen (BUN) and serum creatinine before and after the study intervention are compared. Participants exhibiting significant elevation BUN and S creatine, are classified as having renal injury |
| Secondary | Proportion of Participants With Hematological Adverse Events | 24-48 hours after the completion of study intervention | Hematocrit and platelet counts compared before and after the study intervention; if any significant alteration from baseline, the participant classified as having hematological adverse event, |
| Secondary | Total Number of Days of Mechanical Ventilation | from randomization until discharge/40 weeks post menstrual age | The total number of days on mechanical ventilation are counted as total duration of conventional mechanical ventilation plus high frequency ventilatory days |
| Secondary | Total Number of Days of Need for Supplemental Oxygen | from randomization until discharge/40 weeks post menstrual age | Cumulative days on any supplemental O2 (including Mechanical ventilation., noninvasive ventilation, nasal cannula support) calculated from randomization until 4 weeks of postmenstrual age |
| Secondary | Duration of Noninvasive Ventilation | from randomization until discharge/40 weeks post menstrual age | Total cumulative days on noninvasive ventilation, including NIPPV and nasal CPAP, |
| Secondary | Proportion of Participants With Persistence of Ductus-needing Pharmacological Treatment | from randomization until discharge/40 weeks post menstrual age | Proportion of participants in each group requiring open label treatment with pharmacological agents for ductal closure, e.g. IV Ibuprofen or IV Acetaminophen or IV indomethacin therapies, as decided by the treating physician |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ductus Arteriosus Closure/Constriction Rate | 24-48 hours after the completion of study intervention | None were enrolled for the control arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Echocardiographic Patent Ductus Arteriosus Parameters Before and After the Study Intervention | 24-48 hours after the completion of study intervention | |||
| SECONDARY | Ventilatory Settings Before and After the Study Intervention | 24-48 hours after the completion of study intervention | |||
| SECONDARY | Rate of Liver Injury | 24-48 hours after the completion of study intervention | |||
| SECONDARY | Rate of Renal Injury | 24-48 hours after the completion of study intervention | |||
| SECONDARY | Rate of Hematological Adverse Events | 24-48 hours after the completion of study intervention | |||
| SECONDARY | Total Number of Days of Mechanical Ventilation | from randomization until discharge/40 weeks post menstrual age | |||
| SECONDARY | Total Number of Days of Need for Supplemental Oxygen | from randomization until discharge/40 weeks post menstrual age | |||
| SECONDARY | Duration of Noninvasive Ventilation | from randomization until discharge/40 weeks post menstrual age | |||
| SECONDARY | Rate of Persistence of Ductus-needing Pharmacological Treatment | from randomization until discharge/40 weeks post menstrual age |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ductus Arteriosus Closure/Constriction Rate | Ibuprofen and Acetaminophen Arm (Intervention Arm) | 0 | Participants | ||
| Ductus Arteriosus Closure/Constriction Rate | Ibuprofen and Placebo Arm (Control Arm) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibuprofen and Acetaminophen Arm (Intervention Arm) | 1 | |
| Overall Study | STARTED | Ibuprofen and Placebo Arm (Control Arm) | 0 | |
| Overall Study | COMPLETED | Ibuprofen and Acetaminophen Arm (Intervention Arm) | 0 | |
| Overall Study | COMPLETED | Ibuprofen and Placebo Arm (Control Arm) | 0 | |
| Overall Study | NOT COMPLETED | Ibuprofen and Acetaminophen Arm (Intervention Arm) | 1 | |
| Overall Study | NOT COMPLETED | Ibuprofen and Placebo Arm (Control Arm) | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Biochemical evidence of acute kidney injury with preserved renal function, probably nor related to i | Renal and urinary disorders | Ibuprofen and Acetaminophen Arm (Intervention Arm) | 1 | 1 | |
| other | Biochemical evidence of acute kidney injury with preserved renal function, probably nor related to i | Renal and urinary disorders | Ibuprofen and Placebo Arm (Control Arm) | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibuprofen and Acetaminophen Arm (Intervention Arm) | 1 | 1 |
| Total, all-cause mortality | Ibuprofen and Placebo Arm (Control Arm) | 0 | 0 |
| Total, other adverse events | Ibuprofen and Acetaminophen Arm (Intervention Arm) | 1 | 1 |
| Total, other adverse events | Ibuprofen and Placebo Arm (Control Arm) | 0 | 0 |
| Total, serious adverse events | Ibuprofen and Acetaminophen Arm (Intervention Arm) | 0 | 1 |
| Total, serious adverse events | Ibuprofen and Placebo Arm (Control Arm) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT03701074
GET https://conductscience.org/api/trials/v1/NCT03701074/registered?page=2