A) The general aim of the project: to investigate the effect of Piracetam on children with global developmental delay
Design
Forty children with GDD enter the phase 2 clinical trial. No blinding is done, and the study has no control group.
Settings and conduct
Forty eligible patients referred to the neurology and neurodevelopmental clinics of Zahra Mardani Azari Hospital were given 40 mg of piracetam syrup per their body weight. Their ASQ results, taken before the start of treatment, 3 months after the start of treatment, and 6 months after the beginning of treatment, are compared.
Participants/Inclusion and exclusion criteria
inclusion criteria: 1) chronological age below 5 years and 2) developmental delay in more than or equal to two developmental areas and exclusion criteria include: 1) having metabolic disease or underlying structural disorder, 2) lack of consent It is informed to participate in the study.
Intervention groups
Eligible patients will be given 40 mg of piracetam syrup per body weight per day, and their ASQ results will be compared before, 3 months, and 6 months after starting treatment.
Main outcome variables
1) Improving performance in the field of fine movements
2) Improving performance in the field of gross movements
3) Improving communication performance
4) Improving performance in problem-solving
5) Improving performance in the personal-social field
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039187N14
Registration date:2025-06-06, 1404/03/16
Registration timing:registered_while_recruiting
Last update:2025-06-06, 1404/03/16
Update count:0
Registration date
2025-06-06, 1404/03/16
Registrant information
Name
Elnaz Shaseb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
shasebe@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-19, 1403/10/30
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of piracetam on children with global developmental delay
Public title
The efficacy of piracetam on children with global developmental delay
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age below 5 years and above 2 months
Developmental delay in more than or equal to two developmental domains
Exclusion criteria:
Having a metabolic disease or underlying structural disorder
Lack of informed consent to participate in the study
Age
From 2 months old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
Street address
Khavaran Twon, Zahra Mardani Azari Child Hospital, Tabriz, East Azarbaijan
City
tabriz
Province
East Azarbaijan
Postal code
5267153124
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.TBZMED.PHARMACY.REC.1402.064
Health conditions studied
1
Description of health condition studied
global developmental delay
ICD-10 code
F83
ICD-10 code description
Specific developmental disorder of motor function
Primary outcomes
1
Description
1) Improvement of performance in the area of fine movements 2) Improvement of performance in the area of gross movements 3) Improvement of performance in the area of communication 4) Improvement of performance in the area of problem-solving 5) Improvement of performance in the personal-social area
Timepoint
Evaluation of the developmental form of the ASQ at the beginning of the study, 3 months, and 6 months after the start of the drug
Method of measurement
The effect of Piracetam on improving the development of a person, which is evaluated by the ASQ developmental questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, 40 patients with developmental delay in more than or equal to 2 developmental areas are selected from among the patients referred to the pediatric neurology clinics and the Comprehensive Child Development Center. For these patients, after obtaining informed consent, the Iranian brand Piracetam syrup with the same name, Piracetam, is prescribed at a dose of 40 mg/kg/day once daily. Piracetam belongs to the racetam group, with the chemical name 2-oxo-1-pyrrolidine acetamide. This drug is a cyclic derivative of the neurotransmitter GABA and has the same 2-oxo-pyrrolidone basic structure as pyroglutamic acid. Piracetam is a positive allosteric modulator of the AMPA receptor, acting on ion channels or ion carriers, resulting in increased neuronal excitability. Piracetam affects NMDA glutamate receptors, which are involved in learning and memory processes, through muscarinic cholinergic receptors (ACh), which are involved in memory processes. This drug has been shown to increase oxygen consumption in the brain. The mother is given an age-appropriate ASQ form and is advised to practice, repeat, and teach the age-appropriate activities on the form with her child. Three months later, and six months after starting piracetam, the ASQ forms are completed by the same individual, and their results are compared with those on the previous forms. An improvement in the ASQ score of more than one standard deviation (SD) is considered a response to treatment.