darbepoetin alfa for Perinatal arterial ischemic stroke (PAIS) | Ischemic neonatal stroke

Inclusion criteria

• {"criterion_text":"- Newborns ≥ 36 weeks gestation, both male and female"}
• {"criterion_text":"- MRI confirmed diagnosis of acute PAIS , with involvement."}
• {"criterion_text":"- Written informed consent from custodial parent(s) of the cortical spinal tract (e.g. PLIC or peduncles)"}
• {"criterion_text":"- Less than 4 days after the onset of clinical symptoms"}

Exclusion criteria

• {"criterion_text":"- Moderate –severe HIE with or without hypothermia therapy "}
• {"criterion_text":"- Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder"}
• {"criterion_text":"- Presence of a serious infection of the central nervous system"}
• {"criterion_text":"- No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician"}
• {"criterion_text":"- Infant for whom withdrawal of supportive care is being considered."}

Primary endpoints

• {"endpoint_text":"- Our primary objective is to determine whether there is a difference in the degree in stroke tissue loss between darbepoetin and placebo treatment, which will be measured by the change in lesion size and brain growth between the time of onset of the insult and 6-8 weeks of age. Additionally we will assess whether there are differences between darbepoetin and placebo treatment in DTI parameters of selected regions of interest.","definition_or_measurement_approach":"Measured by the change in lesion size and brain growth between diagnosis and 6-8 weeks of age; assessment of DTI parameters in selected regions of interest."}

Secondary endpoints

• {"endpoint_text":"- We will assess development of USCP, and cognitive development at 18 months of age using the BSID-III and PSOM scores as well as a full neurological assessment including Gross Motor Function Classification system (GMFCS) and several handfunction tests such as Manual Ability Classification System (MACS), the Hand Assessment of Infants (HAI) and Assisting Hand Assessment (AHA) and compare them between groups (darbepoetin vs placebo).","definition_or_measurement_approach":"Assessment at 18 months using BSID-III and PSOM scores, full neurological exam including GMFCS, and hand function tests (MACS, HAI, AHA) to compare darbepoetin vs placebo."}

Netherlands

Earliest CTIS Part Ii Submission Date

06-08-2024

Latest Decision Or Authorization Date

08-08-2024

Processing Time Days

2

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Universitair Medisch Centrum Utrecht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands