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IRCT20221016056205N1 IRCT 2023-05-15 Karaj University of Medical Sciences Comparison of the effect of intra tracheal injection of budesonide with surfactant and surfactant alone in prevention of Bronchopulmonary Dysplasia in preterm infant under ۳۰ week with Respiratory Distress Syndrome A Randomized Cilinical Trial Comparison of the effect of intra tracheal injection of budesonide with surfactant and surfactant alone in prevention of Bronchopulmonary Dysplasia in preterm infant under ۳۰ week with Respiratory Distress Syndrome A Randomized Cilinical Trial 2022-11-22 anticipated 150 Complete https://irct.ir/trial/66532 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: using block randomization with unequal block sizes (4 Two groups of comparison and intervention are interpreted. Confounding Control Method: Randomization of Allocation. Control in the analysis phase is different from statistical models. : Random allocation and concealment and blinding Hidden Privatization: By specifying unequal block sizes, the allocation sequence will be hidden. Pre-randomization list by web-provided software by the co-researcher who is in the interpretation process (https://www.sealedenvelope.com/simple-randomiser/v1/lists) He is not involved in preparing and only this researcher will have access to this list. At the time of identification of the qualified patient, the allocation group will be announced by him based on the prepared list. Blinding: The researcher evaluating the outcome of the specialized group of samples is known According to the fact that the patient is a baby and the parents will also perform the treatment without knowledge. The review of the final results of the study will be done by a doctor who was unaware of the type of intervention. For statistical analysis, a statistical expert is used who is not informed about how people are assigned to groups. Concealment Method Privatization Method: The problem allocation list is only available to the secretary of the department. In order to conceal the randomization process, the sequence of treatment is written on the cards in order, then the cards are placed in sealed envelopes. Each envelope has a random 10-digit code without order and identification of the corresponding patient number, and the only design of the methodologist will be the corresponding code. Because the doctor declares the eligibility of a patient, the secretary provides the envelope to the doctor and the desired treatment is carried out according to the specific type mentioned in the envelope. Preterm infants who meet the conditions for entering the study in the form of available sampling and are placed in one of the following two groups based on the randomization list: mg/kg intervention in the first group including: intratracheal injection of surfactant 200 and followed by . mg/kg and surfactant 200 budesonide 0.25 mg/kg in the second intervention group including intratracheal injection. kg if needed Sampling Type: Available. Randomization method: Using block randomization with unequal block sizes (4-6-8), the samples are assigned to one of the comparison and intervention groups. Confounding Control Method: Randomization of Allocation. Control in the analysis phase is different from statistical models. 3 Bronchopulmonary dysplasia. Intervention 1: Preterm infants who meet the conditions for entering the study are included in the study as available samples and are placed in one of the following two groups based on listrandomization: mg/kg intervention in the first group includes: intratracheal injection of surfactant 200 mg/kg. Intervention 2: Control group: Control group: under sterile conditions, surfactant is prepared in a syringe for the control group, and for the intervention group: surfactant and budesonide are mixed in a syringe and gently shaken to obtain a uniform solution before injection. Medicines are injected intratracheally. In case of surfactant or with budesonide, it can be repeated every 8 hours until a maximum of 6 doses have been received. FiO2 < 0.3, extubation when patients are hospitalized and not discharged, patients are visited daily, in the morning by the neonatologist, if they are discharged, they will be visited again after 72 hours. 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 Sima Kianpishe
Azimiye
Karaj Iran (Islamic Republic of) 1463614636 +98 21 4426 3952 atkntu94@gmail.com Karaj University of Medical Sciences scientific Sima Kianpishe
Azimiye
Karaj Iran (Islamic Republic of) 1463614636 +98 21 4426 5932 atkntu94@gmail.com Alborz University of Medical Sciences Iran (Islamic Republic of) All preterm babies with birth age less than 30 weeks provided they have respiratory distress syndrome (RDS) There is evidence of RDS in chest X-ray and ABG and they are candidates to receive surfactant Babies born at the hip less than 24 weeks of pregnancy - with a birth weight of less than 400 grams - the presence of congenital cardiopulmonary disease - conditions for not entering the study 6 months 7 months Both A baby born less than 24 weeks old A baby with a birth weight of less than 400 grams A baby with a fatal congenital abnormality or disorder Presence of cardiopulmonary diseases P27.1 Bronchopulmonary dysplasia originating in the perinatal period Prevention Prevention Preterm infants who meet the conditions for entering the study are included in the study as available samples and are placed in one of the following two groups based on listrandomization: mg/kg intervention in the first group includes: intratracheal injection of surfactant 200 mg/kg Control group: Control group: under sterile conditions, surfactant is prepared in a syringe for the control group, and for the intervention group: surfactant and budesonide are mixed in a syringe and gently shaken to obtain a uniform solution before injection. Medicines are injected intratracheally. In case of surfactant or with budesonide, it can be repeated every 8 hours until a maximum of 6 doses have been received. FiO2 < 0.3, extubation when patients are hospitalized and not discharged, patients are visited daily, in the morning by the neonatologist, if they are discharged, they will be visited again after 72 hours. Severity of BPD: BPD will be divided into three groups in terms of severity: mild, which means that they do not need oxygen at the age of 36 weeks of pregnancy, and moderate, which means that they need less than 30% of oxygen in the 36th week of pregnancy. Severe need for 30% oxygen with or without positive pressure ventilation or continuous positive pressure at 36 weeks of gestation. Timepoint: After 28 days. Method of measurement: Physical examination. Karaj University of Medical Sciences Approved 2022-09-24 thics committee of Alborz University of Medical Sciences Azimiyeh Karaj Alborz Iran (Islamic Republic of)