Trial · NCT03913221
Caffeine for Hypoxic-Ischemic Encephalopathy
NCT03913221, Phase 1, Completed, University of North Carolina, Chapel Hill; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Caffeine for Hypoxic-Ischemic Encephalopathy. Trials, record NCT03913221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03913221
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caffeine for Hypoxic-Ischemic Encephalopathy
- NCT number
- NCT03913221
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Interventions
- Caffeine Citrate 5 mg/kg, Caffeine Citrate 10 mg/kg
- First posted
- 2019-04-12
- Last updated
- 2025-03-27
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine | 7 samples will be collected with the following optimal sampling windows: 0-15 minutes, 30-60 minutes, 1-3 hours, 3-6 hours, 6-12 hours, 12-18 hours, 15 minutes prior to next dose. | AUC0-t defines area under the plasma concentration-time curve (AUC) from administration to the last quantifiable concentration at time t. |
| Secondary | Number of Participants With Seizures Requiring >1 Anti-Epileptic Medication | From the first dose of caffeine to 7 days following the final dose. | As a potential complication of caffeine exposure, seizure activity requiring \>1 anti-epileptic medication is reported. |
| Secondary | Number of Participants With Necrotizing Enterocolitis | From the first dose of caffeine to 7 days following the final dose. | As a potential complication of caffeine exposure, the number of participants with necrotizing enterocolitis defined as Bell Stage II or III are reported. |
| Secondary | Number of Participants With Abnormal MRI Brain Findings Based on NICHD Neonatal Research Network Score | During initial hospitalization, approximately 7-14 postnatal days | The National Institute of Child Health and Human Development (NICHD) Neonatal Research Network developed and validated an MRI scoring system that categorizes severity of brain injury in the Trial of Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy. A higher score is considered a worse outcome. * Score 0: Normal T2 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 a Bayley Scales of Infant Development (BSID-III) Cognitive, Language, or Motor Composite Score < 85 | 18-24 months of age | The BSID-III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The composite scores are scaled to a metric with a range of 40 to 160, a mean of 100, and a standard deviation of 15. Therefore, children with a composite score \< 85 are 1 standard deviation below the mean in that area. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine | 7 samples will be collected with the following optimal sampling windows: 0-15 minutes, 30-60 minutes, 1-3 hours, 3-6 hours, 6-12 hours, 12-18 hours, 15 minutes prior to next dose. | mg*hr/L | MEAN | |
| SECONDARY | Number of Participants With Seizures Requiring >1 Anti-Epileptic Medication | From the first dose of caffeine to 7 days following the final dose. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Necrotizing Enterocolitis | From the first dose of caffeine to 7 days following the final dose. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Abnormal MRI Brain Findings Based on NICHD Neonatal Research Network Score | During initial hospitalization, approximately 7-14 postnatal days | Two infants died during hospitalization and did not have MRI performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Bayley Scales of Infant Development (BSID-III) Cognitive, Language, or Motor Composite Score < 85 | 18-24 months of age | Bayley-III examinations were planned at the beginning of the study per institutional standard of care. However, during the study period, clinical practice changed, and due to COVID-19 pandemic-related staff turnover, Bayley-III examinations were no longer routinely obtained in Hypoxic-ischemic encephalopathy (HIE) patients. As Bayley-III exams were not included in the study budget and were not a primary study aim, these data were not collected. The protocol was not amended with this change. |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine | Low Dose Caffeine (5 mg/kg) | AUC (0-72) | 1137.36 | Standard Deviation 324.96 | mg*hr/L |
| Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine | High Dose Caffeine (10 mg/kg) | AUC (0-72) | 1177.94 | Standard Deviation 134.42 | mg*hr/L |
| Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine | Low Dose Caffeine (5 mg/kg) | AUC (0-infinity) | 2213.26 | Standard Deviation 540.81 | mg*hr/L |
| Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine | High Dose Caffeine (10 mg/kg) | AUC (0-infinity) | 2768.25 | Standard Deviation 338.06 | mg*hr/L |
| Number of Participants With Seizures Requiring >1 Anti-Epileptic Medication | Low Dose Caffeine (5 mg/kg) | 1 | Participants | ||
| Number of Participants With Seizures Requiring >1 Anti-Epileptic Medication | High Dose Caffeine (10 mg/kg) | 0 | Participants | ||
| Number of Participants With Necrotizing Enterocolitis | Low Dose Caffeine (5 mg/kg) | 0 | Participants | ||
| Number of Participants With Necrotizing Enterocolitis | High Dose Caffeine (10 mg/kg) | 0 | Participants | ||
| Number of Participants With Abnormal MRI Brain Findings Based on NICHD Neonatal Research Network Score | Low Dose Caffeine (5 mg/kg) | Score 0 | 3 | Participants | |
| Number of Participants With Abnormal MRI Brain Findings Based on NICHD Neonatal Research Network Score | High Dose Caffeine (10 mg/kg) | Score 0 | 2 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Low Dose Cohort | STARTED | Low Dose Caffeine (5 mg/kg) | 9 | |
| Low Dose Cohort | STARTED | High Dose Caffeine (10 mg/kg) | 0 | |
| Low Dose Cohort | COMPLETED | Low Dose Caffeine (5 mg/kg) | 9 | |
| Low Dose Cohort | COMPLETED | High Dose Caffeine (10 mg/kg) | 0 | |
| Low Dose Cohort | NOT COMPLETED | Low Dose Caffeine (5 mg/kg) | 0 | |
| Low Dose Cohort | NOT COMPLETED | High Dose Caffeine (10 mg/kg) | 0 | |
| High Dose Cohort | STARTED | Low Dose Caffeine (5 mg/kg) | 0 | |
| High Dose Cohort | STARTED | High Dose Caffeine (10 mg/kg) | 8 | |
| High Dose Cohort | COMPLETED | Low Dose Caffeine (5 mg/kg) | 0 | |
| High Dose Cohort | COMPLETED | High Dose Caffeine (10 mg/kg) | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute Kidney Injury | Renal and urinary disorders | Low Dose Caffeine (5 mg/kg) | 2 | 9 | 2 |
| other | Acute Kidney Injury | Renal and urinary disorders | High Dose Caffeine (10 mg/kg) | 1 | 8 | 1 |
| other | Hepatic Dysfunction | Hepatobiliary disorders | Low Dose Caffeine (5 mg/kg) | 2 | 9 | 2 |
| other | Hepatic Dysfunction | Hepatobiliary disorders | High Dose Caffeine (10 mg/kg) | 0 | 8 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Low Dose Caffeine (5 mg/kg) | 5 | 9 | 5 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | High Dose Caffeine (10 mg/kg) | 2 | 8 | 2 |
| other | Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Low Dose Caffeine (5 mg/kg) | 1 | 9 | 1 |
| other | Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | High Dose Caffeine (10 mg/kg) | 0 | 8 | 0 |
| other | Hypotension | Vascular disorders | Low Dose Caffeine (5 mg/kg) | 1 | 9 | 1 |
| other | Hypotension | Vascular disorders | High Dose Caffeine (10 mg/kg) | 1 | 8 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose Caffeine (5 mg/kg) | 1 | 9 |
| Total, all-cause mortality | High Dose Caffeine (10 mg/kg) | 1 | 8 |
| Total, other adverse events | Low Dose Caffeine (5 mg/kg) | 8 | 9 |
| Total, other adverse events | High Dose Caffeine (10 mg/kg) | 4 | 8 |
| Total, serious adverse events | Low Dose Caffeine (5 mg/kg) | 3 | 9 |
| Total, serious adverse events | High Dose Caffeine (10 mg/kg) | 2 | 8 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low Dose Caffeine (5 mg/kg) vs High Dose Caffeine (10 mg/kg): Number of Participants With Necrotizing Enterocolitis | Trial comparisons |
| Low Dose Caffeine (5 mg/kg) vs High Dose Caffeine (10 mg/kg): deaths from any cause | Trial comparisons |
| Low Dose Caffeine (5 mg/kg) vs High Dose Caffeine (10 mg/kg): Number of Participants With Seizures Requiring >1 Anti-Epileptic Medication | Trial comparisons |
| Low Dose Caffeine (5 mg/kg) vs High Dose Caffeine (10 mg/kg): serious adverse events | Trial comparisons |
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/NCT03913221
GET https://conductscience.org/api/trials/v1/NCT03913221/events?page=2