Trial · NCT06972849
Caffeine Citrate to Improve Neonatal Outcomes.
NCT06972849, Not applicable, Not yet recruiting, University of Melbourne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Caffeine Citrate to Improve Neonatal Outcomes. Trials, record NCT06972849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06972849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caffeine Citrate to Improve Neonatal Outcomes.
- NCT number
- NCT06972849
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 3,900 participants, estimated
- Lead sponsor
- University of Melbourne
- Conditions
- Apnea of Prematurity
- Interventions
- Caffeine citrate
- First posted
- 2025-05-15
- Last updated
- 2025-05-15
Source ClinicalTrials.gov
Registered outcomes13
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 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06972849
GET https://conductscience.org/api/trials/v1/NCT06972849/registered