Trial · NCT05340582
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
NCT05340582, Phase 2, Recruiting, Mount Sinai Hospital, Canada
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants. Trials, record NCT05340582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05340582
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
- NCT number
- NCT05340582
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 310 participants, estimated
- Lead sponsor
- Mount Sinai Hospital, Canada
- Conditions
- Patent Ductus Arteriosus After Premature Birth
- Interventions
- Acetaminophen Injection, Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen), Sodium chloride 0.9% injection
- First posted
- 2022-04-22
- Last updated
- 2026-09-15
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite of pre-discharge mortality or any grade BPD | 36 weeks PMA | Need for oxygen or positive pressure respiratory support at 36 weeks postmenstrual age (PMA) |
| Secondary | PDA treatment success | 6-10 days post treatment initiation | Defined as PDA closure or becoming insignificant \[diameter \<1.5 mm\] |
| Secondary | Renal or hepatic dysfunction | Occurring within 7 days of treatment initiation | Renal dysfunction defined as urine output \< 1ml/kg/hour for the previous 24 hours or serum creatinine \> 100 micromol/L; hepatic dysfunction defined as serum aminotransferase (ALT) \> 100 units/L |
| Secondary | Further exposure to pharmacological PDA treatments | From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization | As per units' standard practice (not part of study procedures) |
| Secondary | Procedure for PDA closure | From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization | Surgical closure for PDA |
| Secondary | Mortality | From date of randomization until date of death (assessed up to a maximum of 250 days after randomization) | Death during initial tertiary NICU stay |
| Secondary | Severity of BPD at 36 weeks PDM using Jensen's criteria | At 36 weeks PDM | Grade 1, nasal cannula ≤2 L/min; grade 2, nasal cannula \>2 L/min or noninvasive positive airway pressure; grade 3, invasive mechanical ventilation |
| Secondary | NEC ≥ stage 2A | From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization | NEC ≥ stage 2A during NICU stay |
| Secondary | Duration (days) of invasive or non-invasive respiratory support | From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization | Days of invasive or non invasive support during NICU say |
| Secondary | Need for diuretic use | From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization | Diuretic use for BPD treatment |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05340582
GET https://conductscience.org/api/trials/v1/NCT05340582/registered