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IRCT20230823059227N1 IRCT 2023-09-13 Karaj University of Medical Sciences "Effect of budesonide nebulizer on reducing BPD" Evaluation of the effect of use of budesonide nebulizer on reducing bronchopulmonary dysplasia in preterm infants less than 32 weeks a randomized of clinical trial 2023-09-22 anticipated 70 Complete https://irct.ir/trial/72205 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Once the eligibility of participants was confirmed and prospective consent obtained, infants were randomly assigned to either receive inhaled budesonide or placebo using the Sealed Envelope web-based randomization software (https://www.sealedenvelope.com) with an allocation ratio of 1:1, Blinding description: To maintain blinding, physicians, data analysts, outcome assessors, and trial investigators were blinded to the randomization group throughout the study. The study medications were prepared by a designated clinical manager who was not involved in clinical care. Both the budesonide and placebo solutions were colorless, indistinguishable in appearance, and prepared in equal volume. The designated clinical manager labeled study medications based on the patient’s code. Outcome data were recorded by a neonatal specialist who was unaware of the administered drugs. All clinical staff, caregivers, the principal investigator and data analysts were blinded during data collection and analysis. 3 Bronchopulmonary dysplasia. Intervention 1: Intervention group: treatment with inhaler Budesonide through jet nebulizer (250 mcg every 12 hours) for 7 days. Intervention 2: Control group:prescribe 3 cc of 0.9% normal saline nebulizer every 12 hours 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 NO More data
public Kobra Hosseini
Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province
Karaj Iran (Islamic Republic of) 3185746957 +98 26 3434 9590 Kobra.hosseini1990@gmail.com Karaj University of Medical Sciences scientific Hani Milani
Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province
Karaj Iran (Islamic Republic of) 3147734568 +98 26 3434 9590 Hanimilani@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Premature neonates between 24 and 32 weeks no limit 1 day Both Weight Less than 500 grams or more than 1500 grams Neonate with fatal congenital abnormalities or disorders and congenital heart and lung diseases Pneumothorax prior to randomization clinical evidence of early onset sepsis prior to randomization P27.1 Bronchopulmonary dysplasia originating in the perinatal period Prevention Placebo Intervention group: treatment with inhaler Budesonide through jet nebulizer (250 mcg every 12 hours) for 7 days. Control group:prescribe 3 cc of 0.9% normal saline nebulizer every 12 hours for 7 days. Bronchopulmonary dysplasia. Timepoint: 36 weeks PMA or discharge to home, whichever occurred first. Method of measurement: According to the NICHD2001 ,The need for supplemental oxygen at 28 PMA. Mortality. Timepoint: daily. Method of measurement: until discharge. The duration of hospitalization. Timepoint: Discharge Time. Method of measurement: The number of days of hospitalization records. Duration of need for oxygen. Timepoint: Daily. Method of measurement: Days count before O2 discontinue. Duration of non-invasive ventilation. Timepoint: Day. Method of measurement: days of non-invasive ventilation. Duration of mechanical ventilation. Timepoint: daily. Method of measurement: days of mechanical ventilation. Intraventricular hemorrhage. Timepoint: daily. Method of measurement: based on cranial ultrasonography. Dr hani milani Approved 2023-09-08 Ethics committee of Alborz University of Medical Science Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province karaj Alborz Iran (Islamic Republic of)