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Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)

Study acronym: EMBRACE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 19, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Lead sponsor: Thayyil, Sudhin to Imperial College Londonv6
  2. Site details revised at 7 of 10 sitesv5
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 1, 2022 to Dec 31, 2022 · Interventions: Erythropoietin (Drug) to Erythropoietin (Drug), Supportive neonatal intensive care (Other) · Eligibility criteria shortened, about 11 words · 2 morev4 Show 5 more changesShow less
    • Start date changed from estimate of Dec 1, 2022 to Dec 31, 2022
    • Interventions: Erythropoietin (Drug) to Erythropoietin (Drug), Supportive neonatal intensive care (Other)
    • Eligibility criteria shortened, about 11 words
    • Study description expanded, about 108 words
    • Site details revised at 10 of 10 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 5 to 10 Study description shortened, about 114 words · Eligibility criteria expanded, about 5 wordsv3 Show 2 more changesShow less
    • Study description shortened, about 114 words
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoint revised Eligibility criteria shortened, about 26 words · Secondary endpoints revised (11) · Study description expanded, about 2 wordsv2 Show 3 more changesShow less
    • Eligibility criteria shortened, about 26 words
    • Secondary endpoints revised (11)
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year. Cooling therapy in the context of modern tertiary intensive care improves outcome after NE in high-income countries. However, the uptake and applicability of cooling therapy in LMICs is poor, due to the lack of intensive care and transport facilities to initiate and administer the treatment within the six-hours window after birth as well as the absence of safety and efficacy data on hypothermia for moderate or severe NE. Erythropoietin (Epo) is a promising neuroprotectant with both acute effects (anti-inflammatory, anti-excitotoxic, antioxidant, and antiapoptotic) and regenerative effects (neurogenesis, angiogenesis, and oligodendrogenesis),which are essential for the repair of injury and normal neurodevelopment when used as a mono therapy in pre-clinical models (i.e without adjunct hypothermia). The preclinical data on combined use of Eythropoeitin and hypothermia is less convincing as the mechanisms overlap. Thus, the HEAL (High dose erythropoietin for asphyxia and encephalopathy) trial, a large phase III clinical trial involving 500 babies with with encephalopathy reported that that Erythropoietin along with hypothermia is not beneficial. In contrast, the pooled data from 5 small randomized clinical trials (RCTs) (n=348 babies), suggests that Epo (without cooling therapy) reduce the risk of death or disability at 3 months or more after NE (Risk Ratio 0.62 (95% CI 0.40 to 0.98). Hence, a definitive trial (phase III) for rigorous evaluation of the safety and efficacy of Epo monotherapy in LMIC is now warranted.
Trial Details
NCT Number NCT05395195
Lead Sponsor Imperial College London
Conditions Encephalopathy, Erythropoietin, Newborn Asphyxia
Enrollment 504 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov