ArticleJournal of perinatology : official journal of the California Perinatal Association2024
A phase I trial of caffeine to evaluate safety in infants with hypoxic-ischemic encephalopathy.
Article in Journal of perinatology : official journal of the California Perinatal Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pharmacokinetics and Safety of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
Who cites it
10 citing papers in PubMed, 8 citations in OpenAlex.
- Preventing pediatric acute kidney injury: is it even possible?Pediatric nephrology (Berlin, Germany) · 2026Review
- The role of persistent inflammation in failed recovery after perinatal brain injury: is resolution the cure?Journal of neuroinflammation · 2026Review
- Caffeine as a Treatment for Perinatal Hypoxic-Ischemic Brain Injury: The Potential Risks and Benefits.Developmental neuroscience · 2026Review
- Editorial: Evaluating efficacy and outcomes in neonatal HIE treatment: A global perspective.Frontiers in pediatrics · 2026Article
- Pharmacological Therapies for Consequences of Perinatal Hypoxic-Ischemic Brain Injury: Where Are We Now?International journal of molecular sciences · 2025Review
- Association of caffeine with renal and other short-term outcomes in neonates with hypoxic-ischaemic encephalopathy undergoing therapeutic hypothermia.BMJ paediatrics open · 2025Article
- Population Pharmacokinetics of Caffeine in Infants with Hypoxic-Ischemic Encephalopathy: A Phase I, Dose-Escalating Trial.Journal of clinical pharmacology · 2025Article
- Neuroprotection for neonatal hypoxic-ischemic encephalopathy: A review of novel therapies evaluated in clinical studies.Developmental medicine and child neurology · 2025Review
- Neonatal encephalopathy due to suspected hypoxic ischemic encephalopathy: pathophysiology, current, and emerging treatments.World journal of pediatrics : WJP · 2024Review
- Methylxanthine use in infants with hypoxic-ischemic encephalopathy: a retrospective cohort study.Scientific reports · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveCaffeine provides neuroprotection following hypoxic-ischemic injury in animals. We characterized the safety of escalating doses of caffeine in infants with hypoxic-ischemic encephalopathy (HIE) receiving therapeutic hypothermia. STUDY
designPhase I trial of infants undergoing therapeutic hypothermia for HIE receiving IV caffeine 20 mg/kg followed by up to two daily doses of 5 mg/kg (n = 9) or 10 mg/kg (n = 8). Safety was evaluated based on adverse events and frequency of pre-specified outcomes compared to data from the Whole-Body Hypothermia for HIE trial (Shankaran, 2005).
resultsTwelve of 17 (71%) infants had ≥1 adverse event during the study period. The frequency of clinical outcomes related to HIE were not statistically different from outcomes in infants receiving hypothermia in the Whole-Body Hypothermia for HIE trial.
conclusionCaffeine administration was well tolerated. A larger study is required to determine the optimal dose and evaluate drug safety and efficacy. CLINICAL TRIAL: ClinicalTrials.gov Identifier: NCT03913221.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.