Trial · NCT05340582
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| Secondary | Need for systemic steroids | 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 | Use for BPD treatment |
| Secondary | Sepsis | 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 | Diagnosis of sepsis during NICU stay |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05340582/registered