Cerebral Palsy Clinical Trial
Official title:
Efficacy and Safety of Cerebrolysin on Neurodevelopmental Outcome of Preterm Infants
Verified date | March 2021 |
Source | Mansoura University Children Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall aim of the study is to assess the effect of Cerebrolysin on physical and mental development of preterm infants by Denver Scale II at different ages of 5, 7 and 12 months
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Months to 1 Year |
Eligibility | Inclusion Criteria: - High risk preterm infants born with gestational age less than 32 weeks and have a corrected postnatal age of 5 months at time of enrollment. Included preterm infants should have one or more of the following risk factors which may affect their neurodevelopmental outcome. 1. Infants diagnosed with bronchopulmonary dysplasia requiring oxygen therapy more than 30% FIO2 at 36 weeks corrected gestational age. 2. Infants with culture proven early or late onset neonatal sepsis with or without neonatal meningitis. 3. Infants diagnosed to have peri- ventricular leukomalacia diagnosed by brain imaging. Exclusion Criteria: 1. Patient with persistent uncontrolled fits (all possible reasons for these uncontrolled seizures, including non-epileptic seizures, pseudo intractability, and medically refractory epilepsy. 2. Patient with brain malformation. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University Children Hospital | Mansourah | El Dakahlya |
Lead Sponsor | Collaborator |
---|---|
Mansoura University Children Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurodevelopmental outcome | Assessment of the physical and mental functions of preterm infant by Denver Developmental Screening Test II (DDST II) | 9 months | |
Secondary | Side effects of cerebrolysin therapy | Sweating, dizziness, increased heart rate and arrhythmia, loss of appetite, diarrhea, constipation, nausea, irritability, insomnia, and allergic reactions. | 9 months |
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