]>
IRCT20190416043290N2 IRCT 2020-12-17 Tehran University of Medical Sciences Comparison of two methods of respiratory support in neonates Comparison of the consequences of using two methods of "continuous positive airway pressure" and "high frequency oscillation" in the treatment of respiratory distress in premature neonates 2020-12-05 anticipated 78 Complete https://irct.ir/trial/52187 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are divided into 2 groups by Blocked Randomization method; Thus, the blocks will be 4 and, considering that the sample size is generally 78 people, 20 blocks of 4 will be considered. N/A respiratory distress of neonates. Intervention 1: Intervention group 1: Infants with a gestational age of 28-34 weeks, weighing less than 2000 grams and hospitalized in the neonatal intensive care unit with a diagnosis of respiratory distress during the first 24 hours of birth, entered the study and accidentally treated with the method of respiratory support as "continuous positive airway pressure " for a maximum of 2-3 days. In this method, a single pronge is used 3-4 centimeters inside the nose. During the treatment, if the baby needs surfactant, based on clinical signs and chest radiography, the method of insure will be operated, and after extubation, the baby will be back to the previous settings. the brand of device used will be "Cindy" or "Ventilator" the amount of oxygen that reaches the patient in each inspiratory is regulated by 40-70% and the positive end expiratory pressure will be 4-6 centimeters of water. Intervention failure in this method is defined as continuous oxygen saturation below 90%, persistence of clinical symptoms or respiratory score above 5. After the disease has healed, other methods such as oxygen therapy with an oxyhood or a mask are used. Intervention 2: Intervention group 2: Infants with a gestational age of 28-34 weeks, weighing less than 2000 grams and hospitalized in the neonatal intensive care unit with a diagnosis of respiratory distress during the first 24 hours of birth, entered the study and accidentally treated with the method of respiratory support as "high frequency oscillation " for a maximum of 2-3 days. In this method, a single pronge is used 3-4 centimeters inside the nose. During the treatment, if the baby needs surfactant, based on clinical signs and chest radiography, the method of insure will be operated, and after extubation, the baby will be back to the previous settings. the brand of device used will be "Stephanie Soufie"; the open airway pressure will be set at 10 centimeters of water and the frequency of the device will be 6-8 hertz. Intervention failure in this method is defined as continuous oxygen saturation below 90%, persistence of clinical symptoms or respiratory score above 5. After the disease has healed, other methods such as oxygen therapy with an oxyhood or a mask are used. Yes - There is a plan to make this available What will be shared: Information on study outcomes can be shared. When: 6 months after publication of results. To whom: Free and academic researchers Conditions: Only information about the outcomes of the study is provided, which is unimpeded if the material and intellectual rights of the Maternal and Fetal Research Center are protected. Where to obtain: Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran, Iran How to obtain: Visit in research center or communication by email: mfnhrc@tums.ac.ir Comments:
public Raheleh Moradi
Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 2357 raheleh.moradi1987@gmail.com Tehran University of Medical Sciences scientific Tahereh Esmaeilnia
Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ 0098 61192357 tesmaeilnia@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All premature neonates (gestational age of 28-34 weeks) Neonates with birth weight less than 2000 gr. Hospitalization in the neonatal intensive care unit due to respiratory distress during the first 24 hours after birth no limit 28 days Both Severe asphyxia (apgar of minutes 5 less than or equal to 6) Positive blood culture upon arrival at the neonatal intensive care unit Congenital malformations (whether pulmonary or extrapulmonary) P22 Respiratory distress of newborn Treatment - Devices Treatment - Devices Intervention group 1: Infants with a gestational age of 28-34 weeks, weighing less than 2000 grams and hospitalized in the neonatal intensive care unit with a diagnosis of respiratory distress during the first 24 hours of birth, entered the study and accidentally treated with the method of respiratory support as "continuous positive airway pressure " for a maximum of 2-3 days. In this method, a single pronge is used 3-4 centimeters inside the nose. During the treatment, if the baby needs surfactant, based on clinical signs and chest radiography, the method of insure will be operated, and after extubation, the baby will be back to the previous settings. the brand of device used will be "Cindy" or "Ventilator" the amount of oxygen that reaches the patient in each inspiratory is regulated by 40-70% and the positive end expiratory pressure will be 4-6 centimeters of water. Intervention failure in this method is defined as continuous oxygen saturation below 90%, persistence of clinical symptoms or respiratory score above 5. After the disease has healed, other methods such as oxygen therapy with an oxyhood or a mask are used. Intervention group 2: Infants with a gestational age of 28-34 weeks, weighing less than 2000 grams and hospitalized in the neonatal intensive care unit with a diagnosis of respiratory distress during the first 24 hours of birth, entered the study and accidentally treated with the method of respiratory support as "high frequency oscillation " for a maximum of 2-3 days. In this method, a single pronge is used 3-4 centimeters inside the nose. During the treatment, if the baby needs surfactant, based on clinical signs and chest radiography, the method of insure will be operated, and after extubation, the baby will be back to the previous settings. the brand of device used will be "Stephanie Soufie"; the open airway pressure will be set at 10 centimeters of water and the frequency of the device will be 6-8 hertz. Intervention failure in this method is defined as continuous oxygen saturation below 90%, persistence of clinical symptoms or respiratory score above 5. After the disease has healed, other methods such as oxygen therapy with an oxyhood or a mask are used. Success or failure of any method. Timepoint: Maximum 3 days. Method of measurement: Need for endotracheal intubation or pulmonary or extrapulmonary complications. Tehran University of Medical Sciences Approved 2020-09-30 Medical Ethics Committee of Tehran University of Medical Sciences Maternal, fetal & Neonatal Research Center, Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)