Trial · NCT06461429
PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]
NCT06461429, Not applicable, Not yet recruiting, University of Melbourne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]. Trials, record NCT06461429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06461429
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]
- NCT number
- NCT06461429
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 100,000 participants, estimated
- Lead sponsor
- University of Melbourne
- Conditions
- Preterm Birth
- Interventions
Erythromycin, Amoxicillin and Erythromycin, Azithromycin, Caffeine citrate 20 mg/kg load and 10 mg/kg daily maintenance., Caffeine citrate 30 mg/kg load and 15 mg/kg daily maintenance., Caffeine citrate 40 mg/kg load and 20 mg/kg daily maintenance
- First posted
- 2024-06-17
- Last updated
- 2025-06-13
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39855752 | DERIVED |
Source PubMed
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/NCT06461429
GET https://conductscience.org/api/trials/v1/NCT06461429/registered?page=2