Trial · NCT06972849
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants who progress by at least one level higher on the PLATIPUS Ordinal Outcome Scale | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier) | The PLATIPUS-Ordinal Outcome Scale ranks the most severe core short-term infant health outcome in the specified time frame. Levels 1-15: 1= Well, liveborn infant; 2= Neonatal unit admission for \<48 hours; 3= Neonatal unit admission for \>/= 48 hours; 4= Non-invasive respiratory support or oxygen therapy for ≥ 4 hours \& \< 5 days; 5= Non-invasive respiratory support or oxygen therapy \>/= 5 days; 6= Mechanical ventilation via endotracheal tube for ≥ 4 hours \& \<7 days; 7= Mechanical ventilation via endotracheal tube for \>/=7 days; 8= Moderate respiratory morbidity; 9=Necrotising enterocolitis AND/OR Sepsis; 10= Severe Respiratory Morbidity; 11= Major Surgery; 12= Brain Injury; 13= TWO of severe respiratory morbidity OR major surgery OR brain injury; 14= Severe respiratory morbidity \& major surgery \& brain injury; 15 = Death. |
| Secondary | Number of infants with moderate respiratory morbidity (as per the primary outcome) | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Number of infants meeting the PLATIPUS-Ordinal Outcome Scale definition of 'moderate respiratory morbidity'. |
| Secondary | Number of infants with severe respiratory morbidity (as per the primary outcome) | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Number of infants meeting the PLATIPUS-Ordinal Outcome Scale definition of 'severe respiratory morbidity'. |
| Secondary | Duration of any positive pressure ventilation, in days | From first date and time (any mode), to final date and time (any mode), up to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier) | Any positive pressure ventilation (mechanical ventilation, non-invasive positive pressure ventilation, continuous positive airway pressure or nasal high-flow therapy), in days (in survivors to 42 weeks' PMA or first discharge home from hospital, whichever is sooner). |
| Secondary | Duration of mechanical ventilation, in days | From start date and time, to end date and time, up to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier) | Mechanical ventilation, in days (in survivors to 42 weeks' PMA or first discharge home from hospital, whichever is sooner). |
| Secondary | Number of infants with patent ductus arteriosus treated with medication or surgery | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier) | Number of infants with patent ductus arteriosus treated with medication or surgery. |
| Secondary | Number of infants with retinopathy of prematurity receiving intraocular or laser treatment | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier) | Number of infants with retinopathy of prematurity receiving intraocular or laser treatment. |
| Secondary | Number of infants treated with postnatal systemic corticosteroids for preterm lung disease | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier) | Number of infants treated with postnatal systemic corticosteroids for preterm lung disease. |
| Secondary | Number of infants with presumed caffeine side-effects | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier) | Number of infants with presumed caffeine side-effects, where the treating clinician has reduced the dose or ceased caffeine. |
| Other | Core Secondary Outcome 1: Number of participants in each, individual component of the primary outcome. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier) | The PLATIPUS-Ordinal Outcome Scale (primary outcome) ranks the most severe core short-term infant health outcome in the specified time frame. Levels 1-15: 1= Well, liveborn infant; 2= Neonatal unit admission for \<48 hours; 3= Neonatal unit admission for \>/= 48 hours; 4= Non-invasive respiratory support or oxygen therapy for ≥ 4 hours \& \< 5 days; 5= Non-invasive respiratory support or oxygen therapy \>/= 5 days; 6= Mechanical ventilation via endotracheal tube for ≥ 4 hours \& \<7 days; 7= Mechanical ventilation via endotracheal tube for \>/=7 days; 8= Moderate respiratory morbidity; 9=Necrotising enterocolitis AND/OR Sepsis; 10= Severe Respiratory Morbidity; 11= Major Surgery; 12= Brain Injury; 13= TWO of severe respiratory morbidity OR major surgery OR brain injury; 14= Severe respiratory morbidity \& major surgery \& brain injury; 15 = Death. |
| Other | Core Secondary Outcome 2: Infant growth measures | At 42 weeks postmenstrual age or first discharge home from hospital (whichever is earliest). | Head circumference (measured in cms), weight (measured in gms), length (measured in cms) and growth z-score will be calculated at 42 weeks postmenstrual age, or first discharge home from hospital (whichever is earliest) |
| Other | Core Secondary Outcome 3: Total duration of first hospitalisation (birth admission) | From date of birth to date first discharged home from hospital | Duration of first hospitalisation, measured in days. |
| Other | Core Secondary Outcome 4: Rate of (any) breastmilk feeding at 42 weeks postmenstrual age, or on the day of first discharge home from hospital. | On the day of 42+0 weeks postmenstrual age or first discharge home from hospital (whichever is earliest) | Any breastmilk feeding (any mode - breast, bottle or tube) at 42 weeks postmenstrual age, or on the day of first discharge home from hospital. |
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/NCT06972849/registered