Trial · NCT06679855
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure | Onset within 48 hours but may last up to 7 days | Composite outcome of post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure. Onset within 48 hours but may last up to 7 days. |
| Secondary | Systemic hypotension | Onset within 48 hours but may last up to 7 days | Either systolic blood pressure below the 3rd percentile for gestational age or mean blood pressure below the postmenstrual age equivalent |
| Secondary | Systemic hypertension | Onset within 48 hours but may last up to 7 days | Systolic blood pressure above the 97th percentile |
| Secondary | Oxygenation failure | Onset within 48 hours but may last up to 7 days | An absolute increase of at least 20% in the fraction of inspired oxygen or mean airway pressure compared with the one-hour post-intervention value that persists for a minimum of 1 hour and occurs within 72 hours of PDA closure |
| Secondary | Ventilation failure | Within 72 hours of PDA closure | Need for high frequency oscillatory ventilation when conventional ventilation strategies fail or a 20% rise in amplitude compared with the one-hour post-intervention value that persists for a minimum of 1 hour and occurs within 72 hours of PDA closure |
| Secondary | Vasopressor score | Within 7 days of PDA closure | Vasopressor score. Minimum score is zero. Higher score is worse, meaning need for higher level of support. VISmax will be calculated as follows: (VIS=dopamine dose \[μg kg-1 min-1\]+dobutamine \[μg kg-1 min-1\]+100×epinephrine dose \[μg kg-1 min-1\]+50×levosimendan dose \[μg kg-1 min-1\]+10×milrinone dose \[μg kg-1 min-1\]+10 000×vasopressin \[units kg-1 min-1\]+100×norepinephrine dose \[μg kg-1 min-1\]) using the maximum dosing rates of vasoactive and inotropic medications (μg kg-1 min-1 or IU kg-1 min-1) |
| Secondary | Use of open-label milrinone or systemic vasodilator after cessation of study drug administration | After study drug cessation and within 7 days of PDA closure | Number of participants using open-label milrinone or systemic vasodilator after cessation of study drug administration |
| Secondary | Time to successful extubation | 36 weeks postmenstrual age | Time to successful extubation, which is defined as extubation for at least 7 days |
| Secondary | Post-intervention Moderate-severe bronchopulmonary dysplasia at 36 weeks' gestation | 36 weeks postmenstrual age | Need for at least 2 liters of high flow nasal cannula at 36 weeks postmenstrual age |
| Secondary | Post-intervention Chronic Pulmonary hypertension | 36 weeks postmenstrual age | presence of septal flattening (or eccentricity index \> 1.3, right ventricular systolic pressure greater than 40 mmHg, or exclusive right to left atrial level shunt on 36-week echocardiography assessment. The presence of a large atrial septal defect, pulmonary vein stenosis or left ventricular diastolic dysfunction will be recorded. |
| Secondary | Post-intervention Periventricular Leukomalacia (PVL) | 36 weeks postmenstrual age | Presence of cystic white matter changes on cranial ultrasound |
| Secondary | Post-intervention Necrotizing Enterocolitis | 36 weeks postmenstrual age | At least Bells stage IIb disease |
| Secondary | Post-intervention Retinopathy of Prematurity (ROP) ≥ stage 3 (according to the international classification) | 36 weeks postmenstrual age | Post-intervention Retinopathy of Prematurity (ROP) ≥ stage 3 (according to the international classification) |
| Secondary | Weight or head circumference z-score change at 36 weeks | 36 weeks postmenstrual age | Weight or head circumference z-score change at 36 weeks (decline by two z-scores will be considered growth failure) |
| Secondary | Death between randomization and discharge from NICU | Randomization to 120 days' postnatal age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 112 days postnatal age) | Death between randomization and discharge from NICU |
| Secondary | Moderate-Severe neurodevelopmental impairment (NDI), using current NRN Follow-Up Study definition | 22 to 26 months | Moderate-Severe neurodevelopmental impairment (NDI), using current NRN Follow-Up Study definition |
| Secondary | Moderate-Severe neurodevelopmental impairment (NDI) or death | 22 to 26 months | Moderate-Severe neurodevelopmental impairment (NDI) or death |
| Secondary | Moderate or severe cerebral palsy | 22 to 26 months | Moderate or severe cerebral palsy |
| Secondary | Severe vision impairment | 22 to 26 months | Severe vision impairment |
| Secondary | Severe hearing impairment | 22 to 26 months | Severe hearing impairment |
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.
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GET https://conductscience.org/api/trials/v1/NCT06679855/registered