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Home › Conditions › hypoxic-ischemic encephalopathy

Hypoxic-ischemic encephalopathy

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for hypoxic-ischemic encephalopathy

14 trials tracked for hypoxic-ischemic encephalopathy: 2 in phase 3 or 4 and 1 with published results. The most-cited published study has 51 citations.

14Trials tracked
2Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 3 2 Phase 2 3 Phase 1 2 Other / NA 7
  1. Phase 3 CEUS Evaluation of Hypoxic Ischemic Injury Completed · 51 cited
  2. Phase 3 Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy Completed
  3. Phase 2 Darbe Administration in Newborns Undergoing Cooling for Encephalopathy Completed
  4. Phase 2 Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial) Completed
  5. Phase 2 Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) Completed
  6. Phase 1 Caffeine for Hypoxic-Ischemic Encephalopathy Completed
Show 8 more trials
  1. Phase 1 Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy Completed
  2. N/A California Transport Cooling Trial Completed
  3. N/A Late Hypothermia for Hypoxic-Ischemic Encephalopathy Completed
  4. N/A Preemie Hypothermia for Neonatal Encephalopathy Completed
  5. N/A Holding, Stress, and Bonding During Therapeutic Hypothermia Completed
  6. N/A Prospective Research in Infants With Mild Encephalopathy Completed
  7. N/A Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy Completed
  8. N/A Predicting Mortality in Patients With Return of Spontaneous Circulation After Cardiac Arrest Completed

Showing the 14 most-cited and recently-updated of 14 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Hypoxic-ischemic encephalopathy: what the trials found

Hypothermia is an established intervention for hypoxic-ischemic encephalopathy. Trials 11 and 13 (both N=168) evaluated hypothermia and are tagged as established, though specific outcome data are not provided in the extracted information. A phase 3 trial 5 (N=256) of a cooling cap (YJW608-04B) is also established, indicating that cooling devices are a recognized therapeutic approach.

Sulfur hexafluoride lipid-type A microspheres were tested in a phase 3 trial 4 (N=1) and are tagged as established, but the single-patient sample size limits generalizability. No outcome data are available for this trial.

Recent results — preliminary, needs further review

  • Dexmedetomidine hydrochloride is under investigation in a phase 2 trial 1 (N=50) for HIE, but no results are yet reported.
  • A sensorimotor intervention is being studied in a trial 2 (N=11) for HIE, but no results are available.
  • A trial 3 (N=168) is ongoing or recently completed, but no intervention or results are specified.
  • Erythropoietin 6 and darbepoetin alfa 7 have been studied in phase 2 trials (N=50 and N=30, respectively) but are tagged as unconfirmed; no outcome data are provided.
  • Caffeine citrate (5 mg/kg) was evaluated in a phase 1 trial 8 (N=17) with abnormal MRI findings reported as 3, 2, 2, 2, 1, 3, but this is unconfirmed and not yet corroborated.

For the clinician treating this condition

  • Hypothermia is a cornerstone therapy for HIE, supported by established trials 51113.
  • Cooling cap devices are an established method for delivering hypothermia 5.
  • Sulfur hexafluoride microspheres have been studied but in a very small trial 4, so evidence is limited.
  • Recent and unconfirmed interventions (e.g., dexmedetomidine, sensorimotor therapy, erythropoietin) require further validation before clinical adoption.

AI synthesis of 10 cited trials, updated Jul 31, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Early enteral feeding during hypothermia for neonatal HIE shows no GI adverse event link
Pediatrics Cohort
Early enteral feeding during hypothermia for neonatal HIE shows no GI adverse event link Early feeding during baby cooling therapy appears safe
This single-center retrospective cohort study of 94 neonates with moderate to severe hypoxic-ischemic encephalopathy (HIE) undergoing therap…
In 94 newborns with brain injury, early feeding during cooling therapy did not raise gut problems and was linked to shorter nutrition suppor…
Frontiers Apr 24, 2026