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IRCT20210110049985N1 IRCT 2021-02-10 Babol University of Medical Sciences The effect of two maintenance doses of caffeine citrate 5 and 10 on premature retinopathy in very low birth weight infants The effect of two maintenance doses of caffeine citrate 5 and 10 on premature retinopathy in very low birth weight infants 2021-01-20 anticipated 100 Complete https://irct.ir/trial/53593 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning the subjects after applying the entry and exit criteria will be randomly assigned in a block method. The randomization unit is individual. The size of the blocks is 4 and in each block, each intervention group will be repeated twice, Blinding description: The ophthalmologist who will play the role of ROP assessor in the studied infants, the physician in charge of the treatment (project manager) and the patient (infant) will be unaware of the study process and the separation of the groups. 1-2 Retinopathy. Intervention 1: Intervention group: The first group receives caffeine citrate at a dose of 5 mg / kg per day. Intervention 2: Intervention group: The second group receives caffeine citrate at a dose of 10 mg / kg per day. Yes - There is a plan to make this available What will be shared: - When: - To whom: - Conditions: - Where to obtain: - How to obtain: - Comments:
public Shahram Moradi
No 19, Amirkola Children’s Hospital
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 hajipour1365@gmail.com Babol University of Medical Sciences scientific Shahram Moradi
No 19, Amirkola Children’s Hospital
Babol Iran (Islamic Republic of) 4731741151 +98 11 3234 6963 hajipour1365@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) All infant who weigh less than 1500 grams. 1 day no limit Both Major anomalies Metabolic diseases H35.1 Retinopathy Treatment - Drugs Treatment - Drugs Intervention group: The first group receives caffeine citrate at a dose of 5 mg / kg per day. Intervention group: The second group receives caffeine citrate at a dose of 10 mg / kg per day. Retinopathy. Timepoint: According to gestational age between 4 to 6 weeks after birth. Method of measurement: Checklist. Babol University of Medical Sciences Approved 2020-11-21 Ethics Committee of Babol University of Medical Sciences Ganjafroz Street Babol Mazandaran Iran (Islamic Republic of)