Comparative survey of the consequences of intratracheal administration of surfactant and surfactant with budesonide in premature infants with respiratory distress syndrome

Determination of the consequences of intratracheal administration of surfactant and surfactant with budesonide in premature infants with respiratory distress syndrome, hospitalized in the neonatal intensive care unit of Kosar Hospital in Qazvin in 2019 year

The clinical trial as a comparative study, with a control group, with parallel, randomized, single-center groups, randomization with the checklist

In infants that are under nasal continuous positive airway pressure and ventilator, gradually flow continues increase to CDP = 6 inches, H2O and FiO2 = 30%. A requirement of FiO2 more than 40% to maintain oxygen saturation in the range of 90 to 95%, survanta is prescribed at a dose of 100 mg / kg and the infant is included in the study. If the infant needs more than 40% FiO2 to maintain acceptable oxygen saturation, survanta should be repeated 6 hours after the first administration. If necessary, the treatment period (4 days) is complete. Before and after the administration of the surfactant, and after that mechanical ventilation management infants are monitored for arterial blood gas and every 12 hours.

Entry conditions: Infants with clinical signs of respiratory distress syndrome, infants with 2 weeks age, infants with surfactant and nasal continuous positive airway pressure; No entry conditions: Infants with congenital anomalies and perinatal asphyxia.

In the intervention group, surfactant is prescribed for infants. In the control group for infants, combination treatment of surfactant with budosonide 0.25 mg is administered intratracheally.

Pneumothorax, Pneumonia, Chronic Pulmonary Disease, Intraventricular Bleeding, Periventricular Leukomalacia, Cardiac Complications, Mortality

Randomization of patients will be done by randomization of 4 blocks (AA, BB-AB, AB-BA, BA-AA, BB). Exactly equal numbers of participants enter the groups at consecutive but equal intervals. Therefore, two groups are considered. In intervention group A patients, for 25 infants with respiratory distress syndrome, Sorvanta at a dose of 100 mg / kg and in intervention group B, for 25 infants with respiratory distress syndrome, Survanta at a dose of 100 mg/kg with budosonide 0.25 mg is administered intratracheally. The administration for each group should be repeated 6 hours after the first administration. If necessary, the treatment period is completed within 4 days. Before and after administration, neonates are tested for ABG (Arterial blood gas) separately in each group. They are then monitored for mechanical ventilation management every 12 hours. The necessary information for the study will be collected using a checklist and finally the consequences of the prescription between the two groups will be analyzed and compared.

In this study, health care personnel (physicians, nurses, physiotherapists, etc.) who are responsible for caring for patients and infants (or parents of infants) are blind.

Information on the main consequences and variables will be presented in the form of a published article.

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Researchers working in academic and scientific institutions, pharmacists and doctors

For therapeutic uses, it can be used with the permission of the authors of the article and by mentioning the source.

Qazvin, Shahid Beheshti Blvd, Beginning of East Palestine, Qods Square, Qods Educational and Medical Center, Postal Code: 34197-59811, E-mail: cgd_rc@yahoo.com, Phone Number: 028-33328709, Fatemeh Tohidnia

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