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IRCT20201222049802N3 IRCT 2022-01-25 Zanjan University of Medical Sciences Comparative study of the effect of dexamethasone and injectable hydrocortisone in reducing the need for oxygen in preterm infants Comparative study of the effect of dexamethasone and injectable hydrocortisone in reducing the need for oxygen in preterm infants with high risk of bronchopulmonary dysplasia admitted to the NICU of Ayatollah Mousavi Hospital in Zanjan in 2021-22. 2021-09-22 anticipated 60 Complete https://irct.ir/trial/61257 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be enrolled randomly in to one of the groups based on inclusion criteria. Randomisation sequence will be processed by Microsoft Excel program via (RANDBETWEEN) command and numbers 0 and 1 will be allocated to each group to choose the group of the subject, Blinding description: The study will be a double-blind study in which the doctor and the patient (patient's mother) will not know the type of drug received by the patient (dexamethasone or hydrocortisone). 3 Bronchopulmonary dysplasia. Intervention 1: Intervention group Dexamethasone: Infants of the dexamethasone group will recieve Dexamethasone injection from day 14 of birth (0.2 mg per kg body weight for the first 3 days and 0.1 mg per kg body weight for the next 4 days). Intervention 2: Intervention group Hydrocortisone: Infants of the hydrocortisone group will recieve hydrocortisone injection from the 14th day of birth (1 mg per kg of body weight for 7 days). 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 The release schedule will be announced soon.
public Asghar Marzban
Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, zanjan, iran.
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3342 0651 Drmarzban@zums.ac.ir Zanjan University of Medical Sciences scientific Asghar Marzban
Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, zanjan, iran.
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3342 0651 Drmarzban@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Fetal age less than 33 weeks The risk of bronchopulmonary dysplasia more than 60% according to the NICHD definition Parental consent Having recieved antenatal corticosteroid no limit 231 days Both Active systemic or pulmonary infection Existence of congenital anomalies and metabolic diseases requiring surgery P27.1 Bronchopulmonary dysplasia originating in the perinatal period Treatment - Drugs Treatment - Drugs Intervention group Dexamethasone: Infants of the dexamethasone group will recieve Dexamethasone injection from day 14 of birth (0.2 mg per kg body weight for the first 3 days and 0.1 mg per kg body weight for the next 4 days). Intervention group Hydrocortisone: Infants of the hydrocortisone group will recieve hydrocortisone injection from the 14th day of birth (1 mg per kg of body weight for 7 days). Oxygen saturation. Timepoint: day 28 of birth. Method of measurement: pulse oximeter. Mechanical ventilation time. Timepoint: day 28 of birth. Method of measurement: Direct observation. CPAP time. Timepoint: day 28 of birth. Method of measurement: Direct observation. NICU hospitalization time. Timepoint: day 28 of birth. Method of measurement: Direct observation. Pulse/Respiration rate. Timepoint: day 28 of birth. Method of measurement: Cardiac monitoring device. Zanjan University of Medical Sciences Approved 2021-09-19 Ethics committee of Zanjan University of Medical Sciences Ayatollah Mousavi Hospital, Above Shahid Sabouti Boulevard, Gavazang Road, Zanjan, Iran. Zanjan Zanjan Iran (Islamic Republic of)