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Cerebrolysin and Neurodevelopment in Preterm Infants

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ClinicalTrials.gov Identifier: NCT03506841
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
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)
Estimated 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
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03506841


Locations
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Egypt
Mansoura University Children Hospital Recruiting
Mansourah, El Dakahlya, Egypt, 35111
Contact: nehad a nasef, MD    01001229299 ext 002    nehad_nasef@yahoo.com   
Sponsors and Collaborators
Mansoura University Children Hospital

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Responsible Party: Nehad Nasef, Professor of Pediatrics, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT03506841     History of Changes
Other Study ID Numbers: Mansoura NICU 2016
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
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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Premature Birth
Obstetric Labor, Premature
Cerebral Palsy
Obstetric Labor Complications
Pregnancy Complications
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrolysin
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents