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IRCT20220920056000N1 IRCT 2023-11-11 Ghoum University of Medical Sciences Evaluation of effect of DHA drop in development progression of gross motor and head circumference in children between 6 month and one years old Has a head growth disorder referred to Hazrat Masoumeh Hospital in Qom in 2022-2023 Evaluation of effect of DHA drop in development progression of gross motor and head circumference in children between 6 month and one years old Has a head growth disorder referred to Hazrat Masoumeh Hospital in Qom in 2022-2023 2023-12-26 anticipated 60 Complete https://irct.ir/trial/65996 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization pattern: block - randomization unit: individual - randomization tool: R software - in a two-way blind way, Blinding description: After obtaining a written consent, medicine is given for 6 months, one group is given only vitamin AD drops and the second group is given AD and DHA drops in the amount of 40 mg. The appearance of the drops is the same and neither the therapist nor the patient can distinguish the type of drops. 3 developmental disorder. Intervention 1: Intervention group: Intervention group: children, both boys and girls (whose number will be equal in both groups) between the ages of 6 months and 1 year, who are referred to Hazrat Masoumeh Hospital in Qom due to developmental disorders and small head circumference. DHA is given to patients in the amount of 40 mg. Intervention 2: Control group: children, both boys and girls (whose number will be the same in both groups) between the ages of 6 months and 1 year, who are referred to Hazrat Masoumeh Hospital in Qom due to developmental disorders and small head circumference after obtaining A written consent is given for 6 months of medication and they only receive vitamin AD drops. Yes - There is a plan to make this available What will be shared: A part of the data such as the information related to the main outcome or the like can be shared. When: The access period starts 6 months after the results are published To whom: Researchers working in academic institutions Conditions: For use in similar research projects Where to obtain: Elham farasat - Hazrat Masoumeh Hospital, Qom How to obtain: Request from the vice president of research Comments:
public Mohsen Mullamohammadi
Qom- Imam Street after Zainuddin Square- Hazrat Masoumeh Hospital
Qom Iran (Islamic Republic of) 3719815539 +98 25 3162 5224 farasat_med@yahoo.com Ghoum University of Medical Sciences scientific Elham Farasat
Emam blv
Qom Iran (Islamic Republic of) 3719815539 +98 25 3162 5224 farasat_med@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Children, both boys and girls, between the ages of 6 months and 1 year, who are referred to Hazrat Masoumeh Hospital in Qom with small head circumference according to their age and developmental disorder. 6 months 1 year Both Allergy symptoms in children Intolerance of drops and vomiting Lack of interest of parents to continue studying Premature babies Cerebral Palsy Metabolic disorder Two or more twins History of head trauma History of brain infection G93.9 Disorder of brain, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: children, both boys and girls (whose number will be equal in both groups) between the ages of 6 months and 1 year, who are referred to Hazrat Masoumeh Hospital in Qom due to developmental disorders and small head circumference. DHA is given to patients in the amount of 40 mg Control group: children, both boys and girls (whose number will be the same in both groups) between the ages of 6 months and 1 year, who are referred to Hazrat Masoumeh Hospital in Qom due to developmental disorders and small head circumference after obtaining A written consent is given for 6 months of medication and they only receive vitamin AD drops Size around the head of children 6 months to one year. Timepoint: Once every 2 months until 6 months, i.e. 4 times (beginning of birth, 2 months, 4 months, and 6 months). Method of measurement: Measure and compare with graph. Development of gross movements of children from 6 months to one year. Timepoint: Once every 2 months until 6 months, i.e. 4 times (beginning of birth, 2 months, 4 months, and 6 months). Method of measurement: Evolution Questionnaire. Ability to acquire movement skills. Timepoint: Once every 2 months until 6 months, i.e. 4 times (beginning of birth, 2 months, 4 months, and 6 months). Method of measurement: Evolution Questionnaire. Ghoum University of Medical Sciences Approved 2022-08-29 Ethics Committee of Qom University of Medical Sciences Pediatric Clinical Research Development Unit, Hazrat Masoumeh Educational and Therapeutic Center, Imam Khomeini Street after Shahid Zainuddin Square, Qom, Iran. Qom Ghoum Iran (Islamic Republic of)