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NCT05624541
Validity and Reliability of Specific Test of Early Infant Motor Performance (STEP) Version 3.0
Conditions: Preterm Birth Complication, Cerebral Palsy, Infant, Premature, Diseases
Sex: All
Ages: 1 Month – 6 Months
Enrollment: 30
Sponsor: Marmara University
Location: Turkey
Summary
Cerebral palsy and other neuromotor disorders are more common in babies born preterm (<37 weeks of gestation), due to various biological and environmental risk factors and the risk increases as the gestational age decreases.
Earlier and more frequent screening with the use of developmental skills tests facilitates referral to early intervention programs.
Current guidelines recommend using some combination of neuroimaging and neurological examination and assessments such as neonatal imaging, general movements (GMs), and Hammersmith Infant Neurological Examination (HINE) for early diagnosis and intervention.
Eligibility Criteria
Inclusion Criteria:Babies born before <37 weeks of gestation and treated in the neonatal intensive care unitInfants with neurologic abnormalities (muscle hypertonia, hypotonia, hyperarousal, and abnormal general movements or cranial ultrasound abnormalities) at moderate to high risk of cerebral palsyInfants referred to physiotherapy due to motor developmental delay and neurological dysfunctionBabies whose age range is between 0-12 months (corrected age will be calculated for premature babies)Being diagnosed as a neurologically and developmentally risky babyBabies who have completed medical treatments and are not in neonatal intensive careInfants of families of infants who agreed to participate in the study and approved the informed consent formExclusion Criteria:Babies with congenital cyanotic heart problems or cystic fibrosisBabies with genetic disease or congenital anomaliesInfants on ventilatorBabies of families who do not accept to work
Source: ClinicalTrials.gov (NCT05624541). StuddyBuddy aggregates publicly available trial information.