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New treatment option for Encephalopathy
Official title Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
ClinicalTrials.gov ID: NCT05395195
What this study is testing
What is Erythropoietin?
Erythropoietin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for encephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 6
You may be able to join if
- (all of below should be met)
- Inborn babies born at a gestational age greater than or equal to 36 weeks, with a birth weight \>=1.8 kg
- At least one of the following: need for continued resuscitation at 5 minutes of age; 5-minute Apgar score \ 16 mmol/L) in cord or blood gas within...
- Moderate or severe neonatal encephalopathy on modified Sarnat staging performed between 1 to 6 hours after birth.
You likely can't join if
- Imminent death at the time of recruitment
- Babies born at home or those admitted after 6 hours of birth.
- Major life-threatening congenital malformations
- Head circumference \<30 cm at birth
- Babies undergoing induced hypothermia
- Migrant family or parents unable/unlikely to come back for follow-up at 18 months
See the full eligibility criteria
- (all of below should be met)
- Inborn babies born at a gestational age greater than or equal to 36 weeks, with a birth weight \>=1.8 kg
- At least one of the following: need for continued resuscitation at 5 minutes of age; 5-minute Apgar score \ 16 mmol/L) in cord or blood gas within the first hour of birth.
- Moderate or severe neonatal encephalopathy on modified Sarnat staging performed between 1 to 6 hours after birth.
- Imminent death at the time of recruitment
- Babies born at home or those admitted after 6 hours of birth.
- Major life-threatening congenital malformations
- Head circumference \<30 cm at birth
- Babies undergoing induced hypothermia
- Migrant family or parents unable/unlikely to come back for follow-up at 18 months
- Sentinel event and encephalopathy occurred only after birth
- Unable to consent in primary language of parent(s)
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Bangladesh
- Aurangabad, India
- Bangalore, India
- Chennai, India
- Hubli, India
- Mumbai, India
- Kelaniya, Sri Lanka
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 hour to 6 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Bangladesh; Aurangabad, India; Bangalore, India; Chennai, India; Hubli, India; Mumbai, India and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.