Early use of Acetazolamide to prevent progression of Intraventricular hemorrhage in preterm newborns - A Double-Blind Randomized Clinical Trial

Use of acetazolamide to prevent the development of intraventricular hemorrhage in premature infants

This study is a double-blind clinical trial in which 132 premature infants were randomly selected (using a random- number- generator computer program) and the intervention group will be given acetazolamide. The control group will also receive a placebo.

This is a double-blind clinical trial study in which 132 patients admitted to Shariati and Imam Khomeini hospitals will be considered from the date of receiving the code of ethics in 1400. Blinding includes the Preparation of 66 packs of acetazolamide tablets and 66 packs of placebo tablets, which are the same in terms of appearance, type of packaging, and color. After assigning the tablets to the two groups, We indicate with labels 1 to 132. The researcher delivers the packages to the therapist and the therapist gives the numbers from 1 to 132 to the patients, respectively. The infants are divided into two groups according to the inclusion criteria.

All infants admitted to the neonatal intensive care unit in Shariati and Imam Khomeini hospitals in Tehran, under the age of 34 weeks or weighing less than 1700 g in 1400, who according to the brain ultrasound performed have grade 2 or higher intraventricular hemorrhage.

The target group received 1-3 mg per kg acetazolamide PO every three hours until complete cessation of intraventricular hemorrhage. The Control group will receive a placebo with the same appearance as acetazolamide.

Duration of hospitalization and change in grade of ventricular hemorrhage and the need for implantation of shunt and seizures and duration of an invasive and non-invasive ventilator and number of deaths and nephrocalcinosis is checked

Using Random number generator computer ( ver.1.1) randomization program, a list of random numbers in the range 1 to 132 will be generated randomly. Random numbers from 1 to 66 will be assigned to the drug and from 67 to 132 to the placebo. Because the order of distribution of these numbers is random, so the assignment of treatment to people who enter the study in order will be done randomly. Finally, this list will be presented to the pharmacist and the order of medicines will be done by the pharmacist in the package, which is the same in terms of shape, appearance, etc. Finally, the therapist will give the pills to the patients using the arrangement of the pills by the drugs.

Because it is a double-blind clinical trial, a randomized list is provided to the pharmacist to produce a sequence that fits the drug packages so that it is identical in appearance and so on. The packages will then be given to the therapist. Patients will be assigned to treatment according to the order of pills from 1 to 132, which includes 66 packs of acetazolamide tablets and 66 packs of placebo pills, which has been done by the pharmacist according to the random list. After the pharmacist prepares the drugs, he will deliver them to the researcher and the researcher will provide them to the therapist. In this case, the therapist does not know which patient is receiving which treatment after randomization.