Trial · NCT05395195
Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
NCT05395195, Phase 3, Recruiting, Imperial College London
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial). Trials, record NCT05395195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05395195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
- NCT number
- NCT05395195
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 504 participants, estimated
- Lead sponsor
- Imperial College London
- Conditions
- Encephalopathy, Erythropoietin, Newborn Asphyxia
- Interventions
- Erythropoietin, Supportive neonatal intensive care
- First posted
- 2022-05-27
- Last updated
- 2024-03-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of babies who die or survive with moderate or severe disability | 18 to 22 months | Death or moderate or severe disability in survivors |
| Secondary | Number of babies who die | Upto 22 months | Mortality from all causes |
| Secondary | Number of babies who survive without neurodisability | 18 to 22 months | Survival with Bayley composite scale scores \>84 in all domains, no cerebral palsy, no seizure disorder, hearing or visual defect |
| Secondary | Number of babies with cerebral palsy | 18 to 22 months | Cerebral palsy with a Gross Motor Function Classification Score \>1 |
| Secondary | Number of babies with microcephaly | 18 to 22 months | Head circumference more than 2 standard deviations below the mean |
| Secondary | Number of babies with gastric bleeds | During neonatal hospitalisation (Expected average of 2 weeks) | Fresh blood \> 5 ml from nasogastric tube |
| Secondary | Number of babies with persistent pulmonary hypertension | During neonatal hospitalisation (Expected average of 2 weeks) | Severe hypoxemia disproportionate to the severity of lung disease with a significant pre-and post ductal saturation difference on pulse oximetry |
| Secondary | Number of babies with coagulopathy | During neonatal hospitalisation (Expected average of 2 weeks) | Prolonged blood coagulation requiring blood products |
| Secondary | Number of babies with intracranial haemorrhage | During neonatal hospitalisation (Expected average of 2 weeks) | Major parenchymal or intraventricular bleed on cranial ultrasound or magnetic resonance imaging. |
| Secondary | Number of babies with culture-proven sepsis | During neonatal hospitalisation (Expected average of 2 weeks) | Isolation of a pathogenic organism from blood or cerebrospinal fluid along with clinical evidence of sepsis or elevation of C-reactive protein |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05395195
GET https://conductscience.org/api/trials/v1/NCT05395195/registered