Cerebrolysin and Neurodevelopment in Preterm Infants

• Sponsor: Mansoura University Children Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03506841
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jun 1, 2016
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Neurodevelopmental outcome [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 [9 months]

   Sweating, dizziness, increased heart rate and arrhythmia, loss of appetite, diarrhea, constipation, nausea, irritability, insomnia, and allergic reactions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Months to 1 Year
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Children Hospital	Mansourah	El Dakahlya	Egypt	35111

Sponsors and Collaborators

• Mansoura University Children Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nehad Nasef, Professor of Pediatrics, Mansoura University Children Hospital
• ClinicalTrials.gov Identifier: NCT03506841
• Other Study ID Numbers: Mansoura NICU 2016
• First Posted: Apr 24, 2018
• Last Update Posted: Mar 15, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebral Palsy; Premature Birth; Cerebrolysin

Study Results

No Results Posted as of Mar 15, 2021