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Cerebrolysin and Neurodevelopment in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03506841
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : March 15, 2021
Information provided by (Responsible Party):
Nehad Nasef, Mansoura University Children Hospital

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

Condition or disease Intervention/treatment Phase
Infant Development Cerebral Palsy Preterm Infant Drug: Cerebrolysin Phase 1

Detailed Description:

There is an inverse relationship between birth weight or gestational age and risk for developmental impairment, with increasing incidence as birth weight or gestational age decreases.

Serious impairment, defined as problems in body function or structure which may be temporary or permanent, is generally a more stable condition and typically leads to a disability requiring rehabilitation. Mild impairment is a more reversible condition amenable to early intervention. Studies that have followed extremely preterm and extremely low birth weight infants into school age and early adulthood have shown higher rates of motor, cognitive or behavioral impairments as compared with infants born at term. The neurologic consequences of extreme prematurity range from mild behavioral and cognitive defects to severe disability. Perinatal neuroprotection aims to reduce these outcomes.

Cerebrolysin is a porcine brain-derived peptide preparation that acts like endogenous neurotrophic factors. It is produced by a standardized enzymatic breakdown of lipid-free brain protein powder and consists of low molecular weight peptides and free amino acids.

The pharmacodynamic effects of Cerebrolysin can be categorized in terms of neuronal survival (e.g. trophic and survival promoting actions), neuroprotection (e.g. limiting neuronal dysfunction, especially in adverse conditions), neuroplasticity (e.g. adaptive responses to changing conditions) and neurogenesis (e.g. promoting differentiation of progenitor cells). We aim to assess the effect of Cerebrolysin on physical and mental development of preterm infants at different ages of life at 5, 7 and 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Cerebrolysin on Neurodevelopmental Outcome of Preterm Infants
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: Cerbrolysin
Preterm 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.
Drug: Cerebrolysin
Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections).

No Intervention: Control
Preterm infants with gestational age less than 32 weeks at birth will receive routine care.

Primary Outcome Measures :
  1. Neurodevelopmental outcome [ Time Frame: 9 months ]
    Assessment of the physical and mental functions of preterm infant by Denver Developmental Screening Test II (DDST II)

Secondary Outcome Measures :
  1. Side effects of cerebrolysin therapy [ Time Frame: 9 months ]
    Sweating, dizziness, increased heart rate and arrhythmia, loss of appetite, diarrhea, constipation, nausea, irritability, insomnia, and allergic reactions.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Months to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03506841

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Mansoura University Children Hospital
Mansourah, El Dakahlya, Egypt, 35111
Sponsors and Collaborators
Mansoura University Children Hospital
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Responsible Party: Nehad Nasef, Professor of Pediatrics, Mansoura University Children Hospital Identifier: NCT03506841    
Other Study ID Numbers: Mansoura NICU 2016
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents