Trial · NCT06461429
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
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 for ≥ 4 hours \& \< 5 days; 5= Non-invasive respiratory support \>/= 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 well liveborn infants | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Well, liveborn infants who have not met the diagnostic criteria for worse scale outcomes. The ordinal outcome scale ranks short-term neonatal outcomes associated with longer-term health in ascending severity. An infant is assigned the outcome that is the highest (worst) for which they have met diagnostic criteria at any time prior to 42 weeks PMA or first hospital discharge (whichever is earlier). |
| Secondary | Number of infants admitted to the neonatal unit during primary hospital admission for 48 hours or more. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants admitted to the neonatal unit during primary hospital admission for 48 hours or more. |
| Secondary | Number of infants admitted to neonatal unit during primary hospital admission for <48 hours. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants admitted to any level of neonatal unit during the birth admission, for less than 48 hours. |
| Secondary | Number of infants who received non-invasive positive pressure respiratory support for ≥ 4 hours (excluding delivery room) and less than 5 days. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants who received non-invasive positive pressure respiratory support for ≥ 4 hours (excluding delivery room) and less than 5 days. |
| Secondary | Number of infants who received non-invasive positive pressure respiratory support for 5 days or more. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants who received non-invasive positive pressure respiratory support for 5 days or more. |
| Secondary | Number of infants who received mechanical ventilation via endotracheal tube for ≥ 4 hours (excluding delivery room) and <7 days. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants who received mechanical ventilation via endotracheal tube for ≥ 4 hours (excluding delivery room) and \<7 days. |
| Secondary | Number of infants who received mechanical ventilation via endotracheal tube for 7 days or more. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants who received mechanical ventilation via endotracheal tube for 7 days or more. |
| Secondary | Number of infants with moderate respiratory morbidity. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants with a gestational age \<37 weeks who received oxygen therapy at 40 weeks' postmenstrual age. |
| Secondary | Number of infants with necrotising enterocolitis OR sepsis. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | A. Infants with necrotising enterocolitis (NEC), defined as one or more of the following: * Radiological diagnosis: Clinical history plus imaging consistent with NEC (pneumatosis intestinalis AND/OR portal venous gas AND/OR persistently dilated loop of bowel on serial imaging) * Clinical diagnosis: Clinical history plus abdominal wall cellulitis and a palpable abdominal mass AND an intention to treat with broad-spectrum antibiotics for 7 days or more OR B. Infants with Sepsis Organism (bacterial, fungal or viral) isolated in the blood or CSF by culture or PCR AND an intention to treat with antimicrobials/antivirals for 5 days or more. NOTE: Exclude if culture is mixed coagulase negative staphylococcus and/or other skin flora contaminant. |
| Secondary | Number of infants with severe respiratory morbidity. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants with severe respiratory morbidity defined as one or more of the following: 1. Tracheostomy, assessed at 42+0 weeks' PMA 2. Discharge home on oxygen AND/OR respiratory support, if discharged prior to or on the day of 40+0 weeks' PMA 3. Born at \<37 weeks' GA AND received respiratory support for 12 hours or more on the day of 40+0 weeks PMA. |
| Secondary | Number of participants who underwent major surgery. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants who underwent major surgery, defined as one of the following: * Laparotomy /Laparoscopy * Thoracotomy/Thoracoscopy (e.g. ligation of a ductus arteriosus, surgery for NEC etc) * Craniotomy / Cranioscopy Excludes inguinal hernia repair. Note: Tracheostomy and neurosurgical intervention for post-haemorrhagic hydrocephalus are included in other categories. |
| Secondary | Number of infants with brain injury. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants with brain injury may be diagnosed on ultrasound or magnetic resonance imaging where there is clinical suspicion or request, and includes one or more of the following: a. Major intraventricular haemorrhage, unilateral or bilateral, defined as i. Papile Grade 3 or 4 AND/OR ii. Moderate-severe periventricular haemorrhagic infarction b. Cystic periventricular leukomalacia, unilateral or bilateral c. Moderate or severe white matter injury on MRI.Other major ischaemic injury such as arterial stroke or hypoxic ischaemic injury d. Post haemorrhagic hydrocephalus requiring drainage. e. Any cerebellar haemorrhage, excluding punctate lesions (\<4mm) that occur in the absence of other brain injury as defined above (12 a, b, c, d and e). |
| Secondary | Number of infants with TWO of Brain Injury OR Major Surgery OR Severe Respiratory Morbidity, who did not experience any worse scale outcomes. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants that meet the definition of TWO of Brain Injury OR Major Surgery OR Severe Respiratory Morbidity (as defined in Scale Categories 10, 11 and 12) |
| Secondary | Number of infants with Brain injury AND Major surgery AND Severe respiratory morbidity. | At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). | Infants that meet the definition of Brain Injury AND Major Surgery AND Severe Respiratory Morbidity (as defined in Scale Categories 10, 11 and 12) |
| Secondary | Number of infants who died | At any time prior to 42 weeks' postmenstrual age or first hospital discharge home from hospital (whichever is earlier). | Death includes fetal death in utero, intrapartum stillbirth, neonatal death, and death before hospital discharge of a liveborn infant. |
| Secondary | Total duration of infant's first hospitalisation, in days | From date of infant birth to date of first discharge home from hospital (or date of death, whichever occurs earlier), assessed up to 12 months. | Total duration of infant's first hospitalisation, in days. An average of three months. |
| Secondary | Any breastmilk feeding (yes/no) at 42 weeks' postmenstrual age or day of first discharge home from hospital (whichever occurs earliest) | At 42 weeks' postmenstrual age or on day of first discharge home from hospital (whichever occurs earliest) | Any breastmilk feeding at 42 weeks' postmenstrual age or on day of first hospital discharge home (whichever occurs earliest). Data will be collected as yes/no. |
| Secondary | Number of infants with diagnosed patent ductus arteriosus (PDA) | At 42 weeks' postmenstrual age or on day of first discharge home from hospital (whichever occurs earliest) | Number of infants diagnosed with PDA. |
| Secondary | Number of infants diagnosed with retinopathy of prematurity (ROP) | At 42 weeks' postmenstrual age or on day of first discharge home from hospital (whichever occurs earliest) | Number of infants diagnosed with retinopathy of prematurity (ROP). Worst stage and treatment will also be collected. |
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/NCT06461429/registered