Cerebrolysin and Neurodevelopment in Preterm Infants
Efficacy and Safety of Cerebrolysin on Neurodevelopmental Outcome of Preterm Infants
1 other identifier
interventional
60
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2018
CompletedFirst Posted
Study publicly available on registry
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMarch 15, 2021
March 1, 2021
3 years
April 13, 2018
March 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Neurodevelopmental outcome
Assessment of the physical and mental functions of preterm infant by Denver Developmental Screening Test II (DDST II)
9 months
Secondary Outcomes (1)
Side effects of cerebrolysin therapy
9 months
Study Arms (2)
Cerbrolysin
ACTIVE COMPARATORPreterm infants with gestational age less than 32 weeks at birth will receive once weekly Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections) starting at the corrected postnatal age of 5 months.
Control
NO INTERVENTIONPreterm infants with gestational age less than 32 weeks at birth will receive routine care.
Interventions
Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections).
Eligibility Criteria
You may qualify if:
- 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.
- Infants diagnosed with bronchopulmonary dysplasia requiring oxygen therapy more than 30% FIO2 at 36 weeks corrected gestational age.
- Infants with culture proven early or late onset neonatal sepsis with or without neonatal meningitis.
- Infants diagnosed to have peri- ventricular leukomalacia diagnosed by brain imaging.
You may not qualify if:
- Patient with persistent uncontrolled fits (all possible reasons for these uncontrolled seizures, including non-epileptic seizures, pseudo intractability, and medically refractory epilepsy.
- Patient with brain malformation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Children Hospital
Al Mansurah, El Dakahlya, 35111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
April 13, 2018
First Posted
April 24, 2018
Study Start
June 1, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
March 15, 2021
Record last verified: 2021-03