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

Determination of the effect of budesonide intratracheal injection in the prevention of bronchopulmonary dysplasia in premature infants with a birth age of less than 30 weeks of gestation and respiratory distress syndrome

A clinical trial with a control group

Kamali Hospital

Premature infants less than 30 weeks of age with respiratory distress syndrome

Preterm infants who meet the conditions for entering the study are included in the study as available sampling and based on the list Randomization falls into one of the following two groups: 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 Budesonide 0.25 mg/kg (0.5 ml/kg) along with 100 mg/kg (1.25 ml/kg if needed)

Examination in terms of oxygen dependence

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.