Trial · NCT05295784
PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
NCT05295784, Phase 1, Withdrawn, University of Arkansas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia. Trials, record NCT05295784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05295784
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
- NCT number
- NCT05295784
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of Arkansas
- Conditions
- Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Caffeine
- Interventions
- Caffeine citrate
- First posted
- 2022-03-25
- Last updated
- 2024-05-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clearance of caffeine | 1 week | Clearance (mL h-1 kg-1) |
| Primary | Volume of distribution of caffeine | 1 week | Volume of distribution (ml/kg) |
| Primary | Peak plasma concentration (Cmax) of caffeine | 1 week | Peak plasma concentration (Cmax) (ng/mL) |
| Primary | Area under the plasma concentration-time curve of caffeine | 1 week | Area under the plasma concentration-time curve from 0 to infinity (AUC0-INF) (mg\*h/L) |
| Primary | Seizure incidence | 2 weeks | Number of neonates who developed seizures based on continuous video electroencephalogram (VEEG) data |
| Primary | Seizure burden | 2 weeks | Electrographic seizures (in minutes per hour) based on continuous video electroencephalogram (VEEG) data |
| Secondary | Acute kidney injury | 10 days | AKI incidence utilizing KDIGO criteria based on urine output and SCr. |
| Secondary | Renal near infrared spectroscopy (NIRS) | 5 days | Investigate changes in renal NIRS values during the therapeutic hypothermia and rewarming period. |
| Secondary | Urine neutrophil gelatinase-associated lipocalin (NGAL) (ng/mL) | 3 days | Urine samples will be collected at 24, 48 and 72 hours after birth. Urine will be analyzed for NGAL. |
| Secondary | Urine kidney injury molecule-1 (KIM-1) (pg/mL) | 3 days | Urine samples will be collected at 24, 48 and 72 hours after birth. Urine will be analyzed for KIM-1. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers32
The papers the trial lists on ClinicalTrials.gov.
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/NCT05295784
GET https://conductscience.org/api/trials/v1/NCT05295784/papers?page=2