Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration (DINOSAUR)
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|ClinicalTrials.gov Identifier: NCT03171818|
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|PAIS Neonatal Stroke Perinatal Stroke||Drug: Darbepoetin Alfa Drug: Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||An international multicenter, randomized placebo controlled intervention study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||This will be a double-blinded study, meaning that both the patient (and his/her parents) and the health care providers, including neonatologist, pediatrician, nurses, physiotherapists, etc, are not allowed to know what treatment the patient has been given. Those that collect outcome parameters, such as MRI data and neurodevelopmental outcome, are also unaware of treatment allocation, meaning that blinding will be maintained during the full study-period of 18 months.|
|Official Title:||Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
Darbepoetin alfa (Aranesp, Amgen)
Drug: Darbepoetin Alfa
Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.
Other Name: Aranesp
Placebo Comparator: Placebo
The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.
Other Name: Sodium Chloride
- Change in stroke tissue loss [ Time Frame: 6-8 weeks of age ]The 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 between the time of onset of the insult and 6-8 weeks of age. The primary endpoint will be estimated using advanced volumetric magnetic resonance (MRI) techniques, performed within one week after clinical presentation and at 6-8 weeks of age.
- Reorganization of corticospinal connectivity [ Time Frame: 6-8 weeks of age ]To assess whether there are differences between darbepoetin and placebo treatment in Diffusion Tensor Imaging (DTI) parameters of selected regions of interest. DTI-MRI techniques are performed at 6-8 weeks of age.
- Neurodevelopment [ Time Frame: 18 months of age ]To assess cognitive and motor development at 18 months of age using the Bayley Scales of Infants and Toddler Development (BSITD)-III scores compare them between groups (darbepoetin vs placebo).
- Neurological assessment [ Time Frame: 18 months of age ]To assess neurological deficit and function using the Pediatric Stroke Outcome Measure (PSOM) and compare this score between groups (darbepoetin vs placebo). The PSOM is performed at 18 months of age.
- Development of Cerebral Palsy [ Time Frame: 18 months of age ]Development of Unilateral Spastic Cerebral Palsy (USCP) using the Gross Motor Function Classification system (GMFCS) and compare this between groups (darbepoetin vs placebo).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171818
|Contact: Manon Benders, MD PhD||+31 88 755 email@example.com|
|Contact: Nienke Wagenaar, MD||+31 88 755 firstname.lastname@example.org|
|Wilhelmina Childrens Hostpital/University Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584 EA|
|Contact: Manon Benders, MD, PhD +31(0)887554545|
|Contact: Nienke Wagenaar, MD +31(0)887554545 ext 63630 email@example.com|
|Principal Investigator: Linda S de Vries, MD, PhD|
|Principal Investigator: Manon JN Benders, MD, PhD|
|Sub-Investigator: Nienke Wagenaar, MD|
|Sub-Investigator: Floris Groenendaal, MD, PhD|
|Sub-Investigator: Jeroen Dudink, MD, PhD|
|Principal Investigator:||Manon Benders, MD PhD||UMC Utrecht|