Trial · NCT06448780
Dose Optimization of Caffeine for HIE
NCT06448780, Phase 1, Active not recruiting, University of North Carolina, Chapel Hill
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Optimization of Caffeine for HIE. Trials, record NCT06448780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06448780
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Optimization of Caffeine for HIE
- NCT number
- NCT06448780
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 16 participants, estimated
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Interventions
- Caffeine citrate 20 mg/kg, Caffeine citrate 30 mg/kg
- First posted
- 2024-06-07
- Last updated
- 2026-08-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Apparent Caffeine Clearance | 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug | Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Caffeine concentrations will be used to calculate population estimates of caffeine clearance, with inter-individual variabilty and residual variabilty . |
| Primary | Volume of Distribution of Caffeine | 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug | Caffeine concentrations will be used to calculate population estimates of volume of distribution with inter-individual variability and residual variability. |
| Secondary | Number of Participants with Pre-Specified Adverse Events | From the first dose of caffeine to 7 days following the final dose. | Safety will be determined by the number of participants with the following: seizures requiring \> 1 anti-epileptic drug, necrotizing enterocolitis defined as Bell Stage II or higher, hypoglycemia defined as point-of-care blood glucose \< 30 mg/dL, and hyperglycemia defined as point-of-care blood glucose \>200 mg/dL. |
| Secondary | Number of Participants with Abnormal MRI Brain Finding Score | During initial hospitalization, typically 3-5 postnatal days | Preliminary effectiveness assessed using the NICHD Neonatal Research Network MRI scoring system that categorizes severity of brain injury in the Trial of Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy. Abnormal MRI is defined as any score \>0. * Score 0: Normal MRI * Score 1A: Minimal cerebral lesions only with involvement of basal ganglia, thalamus * Score 1B: Extensive cerebral lesions * Score 2A: Basal ganglia thalamic, anterior or posterior limb of internal capsule, or watershed infarction * Score 2B: 2A with cerebral lesions * Score 3: Hemispheric devastation |
| Secondary | Number of Participants with Death or Neurodevelopmental Impairment | 18-24 months of age | Preliminary effectiveness assessed based on death or neurodevelopmental impairment defined as: diagnosis of cerebral palsy, hearing impairment requiring hearing aids, blindness, or cognitive, language, or motor score \< 85 on the Bayley Scales of Infant and Toddler Development- Fourth Edition. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23HD111623 | Dose Optimization for Novel Drugs for Infants with Hypoxic-Ischemic Encephalopathy | JACKSON, WESLEY M | UNIV OF NORTH CAROLINA CHAPEL HILL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2023 to 2025 |
Source NIH RePORTER
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/NCT06448780
GET https://conductscience.org/api/trials/v1/NCT06448780/registered