Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT03079167
Eligibility Criteria:
Inclusion Criteria:
* Male or female infants born greater than or equal to 35+0 weeks gestation and able to be randomised less than 23 hours after birth
* One or more of the following indicators of perinatal depression:
1. Apgar less than or equal to 5 at 10 minutes after birth, OR
2. Receiving ongoing resuscitation e.g. assisted ventilation (positive pressure ventilation or CPAP) or chest compressions at 10 minutes after birth, OR
3. on cord blood or arterial or venous blood obtained at less than 60 minutes after birth, either pH less than 7.00 OR base deficit greater than or equal to 12.0 mmol/L
* Moderate to severe encephalopathy, defined between one and six hours after birth by one or both of the following:
1. 3 out of 6 modified Sarnat criteria indicating moderate/severe encephalopathy, OR
2. 2 out of 6 modified Sarnat criteria plus seizure(s) requiring anticonvulsant treatment (diagnosed either clinically or using EEG monitoring) at any time prior to randomisation
* Hypothermia treatment initiated by 6 hours ofa ge; i.e. controlled whole-body cooling planned to continue for 72 hours to a target temperature (adjusted manually or with a device) and subsequent controlled re-warming
* Study treatment planned to start within 24 hours after birth (as soon as feasible after randomisation)
* At least one parent greater than or equal to 18 years of age
* Anticipated ability to collect primary endpoint at 2 years of age
* Signed, written informed parental consent
Exclusion Criteria:
* Contraindications to investigational product
* Indication prior to randomisation for erythropoietin or any other erythropoietic stimulating agent to be given during the first two weeks of life
* Severe intrauterine growth restriction (birth weight less than 1800g)
* Suspected major chromosomal or congenital anomalies
* Head circumference less than 3rd centile below the mean for gestation and gender
* Infant for whom imminent withdrawal of care is being planned
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
23 Hours
Study:
NCT03079167
Study Brief:
Protocol Section:
NCT03079167