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IRCT20230408057850N1 IRCT 2023-04-17 Kerman University of Medical Sciences Comparison of the effectiveness of maintenance doses of caffeine citrate on tracheal tube removal and apnea after it in premature infants Comparison of the effectiveness of maintenance doses of caffeine citrate on tracheal tube removal and apnea after it in premature infants 2023-04-21 anticipated 80 Complete https://irct.ir/trial/69550 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The rand function of Excel software was used for randomization. Based on the random number obtained in the software, the babies are divided into two groups and this process will continue for each group up to 40 people, Blinding description: In this study, the researcher is informed about the division of groups and the parents have received explanations about the research, but they are not informed about the division of groups. Also, the statistician does not know which data belong to the group with high dose of caffeine. 2-3 Tracheal tube extubating and subsequent apnea in premature neonates. Intervention 1: Intervention group: Caffeine citrate with an initial dose of 20 mg per kilogram of body weight per day and a maintenance dose of 10 mg per kilogram of body weight. Intervention 2: Control group: Caffeine citrate with an initial dose of 20 mg per kilogram of body weight per day and a maintenance dose of 5 mg per kilogram of body weight. 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 information"
public Zahra Daei Parizi
Imam highway
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8000 zdaei@kmu.ac.ir Kerman University of Medical Sciences scientific Zahra Daei Parizi
Imam highway
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8000 zdaei@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Neonates with a gestational age of less than 35 weeks Hemodynamic stability during the first 48 hours after mechanical ventilation 1 day 28 days Both Neonates with congenital obstruction and perforation of the gastrointestinal tract Gastroschisis Congenital diaphragmatic hernia Cyanotic heart diseases Other congenital anomalies P28.4 Other apnea of newborn Treatment - Drugs Treatment - Drugs Intervention group: Caffeine citrate with an initial dose of 20 mg per kilogram of body weight per day and a maintenance dose of 10 mg per kilogram of body weight. Control group: Caffeine citrate with an initial dose of 20 mg per kilogram of body weight per day and a maintenance dose of 5 mg per kilogram of body weight. Tracheal extubation failure and subsequent apnea. Timepoint: During the hospitalization period. Method of measurement: Physical examination. Tachycardia. Timepoint: Duration of treatment. Method of measurement: Cardiac monitoring. Nutritional intolerance. Timepoint: Duration of treatment. Method of measurement: Physical examination. Apnea of prematurity. Timepoint: Before and the end of the intervention. Method of measurement: Physical examination. Duration of use of mechanical ventilation. Timepoint: Before and the end of the intervention. Method of measurement: Based on the questionnaire and file information. Hospitalization period. Timepoint: Before and the end of the intervention. Method of measurement: Based on the questionnaire and file information. Necrotizing enterocolitis. Timepoint: Before and the end of the intervention. Method of measurement: Clinical examination and abdominal imaging. Ductus arteriosus remains open. Timepoint: Before and the end of the intervention. Method of measurement: Clinical examination and echocardiography. Kerman University of Medical Sciences Approved 2023-01-17 Ethics committee of Kerman University of Medical Sciences Imam highway Kerman Kerman Iran (Islamic Republic of)