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Home › Conditions › Neonatal encephalopathy

Neonatal encephalopathy

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Neonatal encephalopathy

5 trials tracked for Neonatal encephalopathy: 1 in phase 3 or 4 and 1 with published results. The most-cited published study has 212 citations.

5Trials tracked
1Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 3 1 Phase 2 2 Other / NA 2
  1. Phase 3 High-dose Erythropoietin for Asphyxia and Encephalopathy Completed · 212 cited
  2. Phase 2 Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) Completed
  3. Phase 2 Mild Encephalopathy in the Newborn Treated With Darbepoetin Completed
  4. N/A Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings Completed
  5. N/A CoolCap Followup Study-Coordination of Participating Centers Completed

Showing the 5 most-cited and recently-updated of 5 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 For clinicians

Neonatal encephalopathy: what the trials found

Clinical data regarding the management of neonatal encephalopathy includes evaluations of standard care outcomes. In a Phase 3 study (N=500), infants receiving a normal saline placebo demonstrated Bayley III Cognitive Scores of 89.1 and 89.5, respectively, and Bayley III Language Scores of 87.9 and 86.7 1.

In the same Phase 3 trial, the number of participants with behavioral abnormalities (determined by the externalizing score of the Child Behavior Checklist) was recorded at 15 in one group and 3 in the other 1.

Recent results — preliminary, needs further review

  • A study involving telemedicine consults for this condition was conducted with a sample size of 115 4.

For the clinician treating this condition

  • Baseline cognitive and language scores have been established in large-scale trials using saline placebos 1.
  • Behavioral abnormalities are documented outcomes in the assessment of neonatal encephalopathy 1.

AI synthesis of 2 cited trials, updated Jun 24, 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.
Melatonin treatment in term or late preterm newborns with neonatal encephalopathy shows very uncertain effects on mortality or disability
Pediatrics Meta-analysis
Melatonin treatment in term or late preterm newborns with neonatal encephalopathy shows very uncertain effects on mortality or disability Could Melatonin Protect Newborn Brains? We Still Don't Know
This systematic review and meta-analysis evaluated melatonin in newborns with neonatal encephalopathy.
Melatonin shows promise in animal studies for protecting newborn brains from oxygen injury, but human trials are too few to guide treatment …
Apr 14, 2026