23 completed, 8 recruiting, 4 unknown, 3 not yet recruiting. 11 Phase 1, 11 Phase 2, 9 Phase 3, 7 Phase 4, 6 Not applicable.
Follow caffeine citrate: new trials by email Literature Review of caffeine citrate trials Research Report on caffeine citrate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO) Caffeine citrate, Saline (NaCl 0,9 %) (placebo) - Meconium Aspiration Syndrome | Phase 2 | Not yet recruiting | University of Alberta | 20 | 2026-09-01 | 2026-06-01 |
| Caffeine Optimization for Oxygen Saturation Index in ELBW Infants Caffeine Citrate - Neonatal Apnea, Infants | Phase 2 | Recruiting | University of Rochester | 40 | 2026-07-15 | 2026-07-29 |
| Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia Caffeine citrate 20mg/kg/day, Placebo-Sterile water 1ml/kg/day - Premature Infant Disease, Apnea of Prematurity | Phase 4 | Recruiting | University of Alabama at Birmingham | 340 | 2026-06-17 | 2026-06-23 |
| Pharmacokinetics and Placental Transfer of Caffeine Caffeine citrate - Preterm Labor With Preterm Delivery, Premature Birth | Phase 1 | Recruiting | Indiana University | 30 | 2026-06-01 | 2026-06-04 |
| Improving Preterm Kidney Outcomes With Caffeine Caffeine citrate, Placebo - Kidney Injury, Pre-Term | Phase 2 | Recruiting | University of Wisconsin, Madison | 114 | 2026-05-28 | 2026-09-18 |
| Caffeine for Hypoxic Ischemic Encephalopathy Caffeine citrate oral solution, Oral placebo solution - Hypoxic Ischemic Encephalopathy (HIE) | Phase 3 | Recruiting | NICHD Global Network for Women's and Children's Health | 830 | 2026-04-08 | 2026-06-24 |
| PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol] Erythromycin, Amoxicillin and Erythromycin, Azithromycin - Preterm Birth | Not applicable | Not yet recruiting | University of Melbourne | 100000 | 2025-11-01 | 2025-06-13 |
| Caffeine Citrate to Improve Neonatal Outcomes. Caffeine citrate - Apnea of Prematurity | Not applicable | Not yet recruiting | University of Melbourne | 3900 | 2025-10-01 | 2025-05-15 |
| To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers KP-001, Rosuvastatin calcium10mg, Caffeine citrate - Healty Volunteers | Phase 1 | Completed | Kaken Pharmaceutical | 38 | 2025-02-13 | 2025-09-12 |
| Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population Caffeine citrate 15mg/kg, 0.9% Sodium Citrate - Enhanced Recovery After Surgery in a Pediatric Population | Phase 1 / Phase 2 | Recruiting | University of Chicago | 100 | 2024-09-09 | 2025-09-12 |
| Dose Optimization of Caffeine for HIE Caffeine citrate 20 mg/kg, Caffeine citrate 30 mg/kg - Hypoxic-Ischemic Encephalopathy | Phase 1 | Active not recruiting | University of North Carolina, Chapel Hill | 16 | 2024-07-26 | 2026-08-14 |
| Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It. High-Dose, Low Dose - Apnea of Prematurity | Phase 1 | Active not recruiting | Nishtar Medical University | 114 | 2024-06-03 | 2025-04-01 |
| PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia Caffeine citrate - Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy | Phase 1 | Withdrawn | University of Arkansas | 2024-05-08 | 2024-05-10 | |
| The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate Caffeine citrate - Apnea of Prematurity, Premature Birth | Phase 4 | Recruiting | Semmelweis University | 226 | 2023-12-21 | 2024-05-06 |
| the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy Caffeine citrate, Amikacin - Pharmacological Action of Drug | Early Phase 1 | Unknown | Al-Azhar University | 50 | 2023-10-19 | 2023-10-24 |
| Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress Caffeine citrate, Placebo - Prematurity, Respiratory Disease | Phase 2 / Phase 3 | Recruiting | Ministry of Health, Saudi Arabia | 134 | 2023-10-12 | 2025-06-27 |
| Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis Caffeine, Metoprolol, Midazolam - Atopic Dermatitis | Early Phase 1 | Completed | Amgen | 21 | 2023-06-03 | 2025-12-23 |
| The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study Dextrose Water, Caffeine citrate - Postoperative Delirium, Postoperative Cognitive Dysfunction | Phase 2 | Completed | University of Michigan | 250 | 2023-02-20 | 2026-07-16 |
| CaffeinICU Study - A Study on Oral Caffeine in ICU Patients With Coma Caffeine Citrate 20 MG/ML Oral Solution - Depressed GCS | Phase 2 | Suspended | Singapore General Hospital | 10 | 2022-11-24 | 2024-06-27 |
| Caffeine Citrate Use and Electronic Activity of the Diaphragm (EDI) Changes caffeine citrate - Preterm, Apnea of Prematurity | Completed | Seoul St. Mary's Hospital | 14 | 2022-06-08 | 2023-11-28 |
Showing 20 of 47. Sign in to see all of them.
Apnea (20) · Premature Birth (14) · Bronchopulmonary Dysplasia (4) · Hypoxia-Ischemia, Brain (4) · Acute Kidney Injury (2) · Cognitive Dysfunction (2) · Emergence Delirium (2) · Obstetric Labor, Premature (2) · Respiratory Distress Syndrome (2) · Respiratory Insufficiency (2) · Alzheimer Disease (1) · Anxiety Disorders (1) · Brain Injuries (1) · Bronchiolitis (1) · Delirium (1)
Ain Shams University (2) · McMaster University (2) · University of Chicago (2) · University of Melbourne (2) · University of Michigan (2) · University of North Carolina, Chapel Hill (2) · Al-Azhar University (1) · American SIDS Institute (1) · Amgen (1) · Boston Children's Hospital (1) · Children's Hospital of Chongqing Medical University (1) · Duke University (1) · Hacettepe University (1) · Hadassah Medical Organization (1) · Hamad Medical Corporation (1)
United States (22) · Egypt (4) · Australia (2) · Canada (2) · Israel (2) · Pakistan (2) · Saudi Arabia (2) · United Kingdom (2) · Zambia (2) · Bangladesh (1) · China (1) · Democratic Republic of the Congo (1) · Germany (1) · Guatemala (1) · Hungary (1)
Phillip Vlisides, MD (2) · Wesley M Jackson, MD, MPH (2) · Aaron Fox, PhD (1) · Alfonso Solimano, MD (1) · Anna Thomas, MD (1) · Anup Katheria, MD (1) · Arne Ohlsson, MD (1) · Barbara K Schmidt, MD (1) · Bassem El Sayed (1) · Betty McEntire, PhD (1) · Brett Manley, MBBS, PhD (1) · Brett Manley, MBChB PhD (1) · Carole Marcus, M.B.B.Ch. (1) · Christopher Black, PhD (1) · Clare Whitehead, MBChB, PhD (1)
PMID 10364418, PMID 11412143, PMID 11782649, PMID 11838581, PMID 15879163, PMID 16707748, PMID 17989382, PMID 19926098, PMID 21173002, PMID 22253394, PMID 24445955, PMID 24496539, PMID 24840756, PMID 25126039, PMID 25171195, PMID 25641237, PMID 25784749, PMID 27189681, PMID 28437520, PMID 28707987, PMID 29519541, PMID 32215834, PMID 33277284, PMID 33900493, PMID 36301511, PMID 37188468, PMID 37587184, PMID 39140727, PMID 39804861, PMID 39855752, PMID 40294395, PMID 8568662, PMID 9279815
K23HD111623 (1), R01AG075005 (1), R01GM116119 (1), R01HD057098 (1), R01HD116793 (1), R01HL098045 (1), U10HD036790 (1), U54HD071594 (1), UG1HD021364 (1), UG1HD027851 (1), UG1HD027853 (1), UG1HD027880 (1), UG1HD027904 (1), UG1HD034216 (1), UG1HD040492 (1)