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IRCT20210607051507N3 IRCT 2021-10-06 Tehran University of Medical Sciences To evaluate the effect of acetazolamide in the prevention of intraventricular hemorrhage in preterm newborns Early use of Acetazolamide to prevent progression of Intraventricular hemorrhage in preterm newborns - A Double-Blind Randomized Clinical Trial 2021-09-06 anticipated 132 Complete https://irct.ir/trial/58187 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Due to the low dose of acetazolamide used in this study, there will be no side effects and in all studies performed in the years before furosemide and acetazolamide have been used together and in very high doses up to 100 mg per day, Randomization description: 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, Blinding description: 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. 3 Intracranial hemorrhage in preterm newborns. Intervention 1: Intervention group: They receive acetazolamide at a dose of 1-3 mg per kg per oral every three hours until complete recovery from intraventricular bleeding. Intervention 2: Control group: Newborns with the inclusion criteria will receive a placebo with the same appearance as acetazolamide. Due to the low dose and low weight of infants, the main drug is colorless in dilution and distilled water is used as a placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information
public Ameneh Lamsehchi
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Opposite the Faculty of Economics, Dr. Shariati Research and Treatment Center
Tehran Iran (Islamic Republic of) 1411713135 00084901-021 lamsehchila@gmail.com Tehran University of Medical Sciences scientific Setareh Sagheb
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Opposite the Faculty of Economics, Dr. Shariati Research and Treatment Center
Tehran Iran (Islamic Republic of) 1411713135 +98 21 0008 4901 dr.ssagheb@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) All infants admitted to the neonatal intensive care unit at Shariati and Imam Khomeini Hospitals in Tehran under the age of 34 weeks or weighing less than 1700 g in 2020-2021 According to the brain ultrasound performed, they have intraventricular hemorrhage of grade two and above no limit no limit Both Syndromic cases cases with genetic diseases infants with metabolic and neuromuscular diseases cyanotic heart disease necrotizing enterocolitis gastrointestinal bleeding P52.3 Unspecified intraventricular (nontraumatic) hemorrhage of newborn Treatment - Drugs Placebo Intervention group: They receive acetazolamide at a dose of 1-3 mg per kg per oral every three hours until complete recovery from intraventricular bleeding. Control group: Newborns with the inclusion criteria will receive a placebo with the same appearance as acetazolamide. Due to the low dose and low weight of infants, the main drug is colorless in dilution and distilled water is used as a placebo. Duration of admission. Timepoint: Duration of hospitalization of the infant from the start of medication to complete recovery of cerebral hemorrhage and discharge. Method of measurement: Extract the date of hospitalization and discharge from the file. Change in the degree of ventricular hemorrhage. Timepoint: within ten days and one month from the start of acetazolamide. Method of measurement: Neonatal brain ultrasound and extraction report. Requirement of shunts. Timepoint: during of Hospitalization. Method of measurement: file review. Seizures. Timepoint: during hospitalization. Method of measurement: file review. Duration of use of invasive and non-invasive ventilator. Timepoint: during hospitalization. Method of measurement: file review. Death number of neonates. Timepoint: during hospitalization. Method of measurement: file review. Nephrocalcinosis. Timepoint: on one-month. Method of measurement: ultrasound sonography. Evalution of development. Timepoint: at a modified four-month age. Method of measurement: based on ASQ. Neonatal head circumference (examination of microcephaly or macrocephaly). Timepoint: Corrected age of three months. Method of measurement: meter(cm). Hearing change. Timepoint: at the corrected age of three months. Method of measurement: ABR audiometer. Tehran University of Medical Sciences Approved 2021-08-12 Ethics Committee of Tehran University of Medical Sciences Tehran, Keshavarz Blvd., Corner of Ghods St., Central Organization of the University, Sixth Floor, Vice Chancellor for Research and Technology, Secretariat of the Ethics Committee in University Biomedical Research - Room 605 Tehran Tehran Iran (Islamic Republic of)