Cerebral Palsy Clinical Trial
Official title:
Effect of Early Application of Recombinant Human Erythropoietin in Premature Infants on White Matter Lesions and Neurodevelopmental Outcome
Preterm and very preterm infants are at risk of developing encephalopathy of prematurity and long-term neurodevelopmental delay. Magnetic resonance imaging (MRI) allows the characterization of specific features of encephalopathy of prematurity, including structural changes of brain white matter and gray matter. This study wants to investigate important evidence that early repeated high-dose rhEPO(5250 IU/kg) treatment improves long-term neurological outcomes in very preterm infants and without obvious adverse effects.
HYPOTHESIS Early administration of human erythropoietin (EPO) in preterm infants reduces
perinatal injury to the brain and improves neurodevelopmental outcome at 24 months corrected
age.
PRIMARY OBJECTIVE To determine whether cerebral outcome is improved if infants born between
28 0/7 and 34 6/7 gestational weeks at birth receive erythropoietin in high dose in the first
two weeks after birth.
Biomarkers of encephalopathy of prematurity assessed on magnetic resonance imaging (MRI) at
term equivalent age.
RATIONALE Erythropoietin (EPO) was first recognized for its hematopoietic properties;
recombinant human EPO (rhEPO) has been used to treat a number of anemic states, including
early and late anemia of prematurity, and it has been found to be safe and to reduce the need
for blood transfusions. EPO produced in the central nervous system7 is upregulated after
insult and plays a role in neuroprotection. Experimental studies have reported that rhEPO
possesses neuroprotective properties in different neonatal brain injury animal models, and
clinical studies have shown that rhEPO treatment reduces brain injury and the incidence of
neurological disabilities in infants.8,14-17 In addition, improved neurodevelopmental
outcomes have been observed in preterm infants with anemia after rhEPO treatment. The
neuroprotective effect of rhEPO was suggested to be through acting against apoptosis,
inflammation, and neurotoxicity and by acting as an antioxidant in protecting white matter
from injury and in promoting neural regeneration, injury repair, and normal development.
STUDY DESIGN Randomized, double-masked, placebo-controlled multicenter clinical trial.
Research plan 400 infants will be randomized during the first three hours of life to receive
EPO (5250 U/kg body weight) or placebo intravenously, the first dose(750U/kg) will be
injected within 24h after birth, subsequent injection will be given each other day for 2
weeks. Standardized evaluation including cerebral sonography at day 1, 7 and 28 will
determine the presence or absence of complications. Cerebral volume and white matter volume
will be assessed at 40 postmenstrual weeks with MRI (only if available).
Experienced examiners will assess developmental function at 6 and 12 months corrected age
using the reliable and validly revised Bayley Scales III of Infant Development and determine
the presence or absence of impairment of motor function (cerebral palsy) and neurosensory
function (blindness or deafness).
Primary outcome was cognitive development assessed with the Mental Development Index (MDI;
norm, 100 [SD, 15]; higher values indicate better function) of the Bayley Scales of Infant
Development, second edition (BSID-II) at 1 years corrected age.
Second outcome assess the effect of early administration of rh Epo on white matter
development in preterm infants using Tract-based spatial statistics (TBSS ). White matter
disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent
age based on an established scoring method.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05317234 -
Genetic Predisposition in Cerebral Palsy
|
N/A | |
Recruiting |
NCT05576948 -
Natural History of Cerebral Palsy Prospective Study
|
||
Completed |
NCT04119063 -
Evaluating Wearable Robotic Assistance on Gait
|
Early Phase 1 | |
Completed |
NCT03264339 -
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
|
N/A | |
Completed |
NCT05551364 -
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT03902886 -
Independent Walking Onset of Children With Cerebral Palsy
|
||
Recruiting |
NCT05571033 -
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
|
N/A | |
Not yet recruiting |
NCT04081675 -
Compliance in Children With Cerebral Palsy Supplied With AFOs
|
||
Completed |
NCT02167022 -
Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy
|
N/A | |
Completed |
NCT04012125 -
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
|
N/A | |
Enrolling by invitation |
NCT05619211 -
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
|
Phase 1 | |
Completed |
NCT04489498 -
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
|
||
Completed |
NCT03677193 -
Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
|
N/A | |
Recruiting |
NCT06450158 -
Robot-assisted Training in Children With CP
|
N/A | |
Completed |
NCT04093180 -
Intensive Neurorehabilitation for Cerebral Palsy
|
N/A | |
Completed |
NCT02909127 -
The Pediatric Eating Assessment Tool
|
||
Not yet recruiting |
NCT06377982 -
Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy
|
Phase 1 | |
Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
Not yet recruiting |
NCT03183427 -
Corpus Callosum Size in Patients With Pineal Cyst
|
N/A | |
Active, not recruiting |
NCT03078621 -
Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy
|
Phase 1/Phase 2 |