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IRCT2016111930964N1 IRCT 2016-12-30 Vice Chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences Study of two non-invasive ventilation methods in the treatment of acute respiratory distress syndrome of infants Efficacy of continuous positive oscillatory nasal airway pressure versus continuous positive nasal airway pressure in neonates with 28-34 weeks of gestational age with respiratory distress syndrome: A randomized controlled trial 2016-06-05 anticipated 128 Complete https://irct.ir/trial/24453 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized based on a random number table. 3 respiratory distress syndrome in new borns. Intervention 1: Intervention 1: Eligible newborns were randomly allocated to the ‘Oscillatory NCPAP’ group. For this purpose, cno ncpap device ( made in Germany) was employed. Using this device, nasal continuous positive airway pressure with vibration was given to the patient. INSURE (intubation, surfactant treatment and extubation) technique would have been used if the patient had needed PEEP ≥5 cm/H2o and Fio2 ≥ 40%. The orogastric tube was kept open and suspended from the top wall of the incubator to decompress the stomach. Pulse oximeter saturation, respiratory rate and heart rate were continuously monitored. Blood pressure was measured at least every 6 hours. ABG was performed after 30 min of starting respiratory support, then, at least every 6 hours in first 24 hours and every 8 hours in next 24 h and as indicated. We used oscillatory NCPAP with PEEP 4-6 cm of water, fraction of inspired oxygen (Fio2) of 0.4, frequency of 3 HZ and amplitude of 3 cm H2O. Maximum permissible PEEP was 8 cm and maximum permissible Fio2 was 0.6. Maximum permissible frequency and amplitude were at the time that we observed oscillation on chest wall (Maximum frequency of 5 HZ and amplitude of 7 cm H2O). Settings was adjusted based on arterial blood gases (ABG) and clinical parameters. Targeted saturation was ≥ 90 %. Intervention 2: Intervention 2: Eligible newborns were randomly allocated to the ‘NCPAP’ group. For this purpose, sindi ncpap device (made in Germany) was employed. Using this device, nasal continuous positive airway pressure was given to the patient. INSURE (intubation, surfactant treatment and extubation) technique would have been used if the patient had needed PEEP ≥5 cm/H2o and Fio2 ≥ 40%. The orogastric tube was kept open and suspended from the top wall of the incubator to decompress the stomach. Pulse oximeter saturation, respiratory rate and heart rate were continuously monitored. Blood pressure measured at least every 6 h. ABG was performed after 30 min of starting respiratory support, then, at least every 6 h in first 24 h and every 8 h in next 24 h and as indicated. We used NCPAP with PEEP equal to 4-6 cm of water and fraction of inspired oxygen (Fio2) equal to 0.4. Maximum permissible target was 8 cm for PEEP and 0.6 for Fio2. Settings was adjusted based on arterial blood gases (ABG) and clinical parameters. Targeted saturation was ≥ 90 %.
public Shiva Bashirnejad khabaz
The main door of Ahvaz Jundishapur University of Medical Sciences and Health Services, opposite the Khuzestan Water and Electricity Authority (five storeys), Golestan highway, Ahvaz
Ahvaz Iran (Islamic Republic of) 1579461357 +98 613367543 bashirnejad.sh@ajums.ac.ir; sh.bashirnejad@gmail.com Ahvaz Jundishapur University of Medical Sciences scientific Arash Malekian
The main door of Ahvaz Jundishapur University of Medical Sciences and Health Services, opposite the Khuzestan Water and Electricity Authority (five storeys), Golestan highway, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 613367543 malekianarash@gmail.com Ahvaz Jundishapur University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Preterm infants at gestational age of 28 to 34 weeks; weight between 1000 and 2000 grams; respiratory distress syndrome; Silverman-Anderson retraction score 6 - 7. Exclusion criteria: Congenital malformation; cardiac disease; severe asphyxia (Apgar score ≤ 3 at 1 and 5 minute or pH ≤ 7.12); parents' unwillingness to participate in the study. no limit 1 day Both P22.0 Respiratory distress syndrome of newborn Treatment - Other Treatment - Other Intervention 1: Eligible newborns were randomly allocated to the ‘Oscillatory NCPAP’ group. For this purpose, cno ncpap device ( made in Germany) was employed. Using this device, nasal continuous positive airway pressure with vibration was given to the patient. INSURE (intubation, surfactant treatment and extubation) technique would have been used if the patient had needed PEEP ≥5 cm/H2o and Fio2 ≥ 40%. The orogastric tube was kept open and suspended from the top wall of the incubator to decompress the stomach. Pulse oximeter saturation, respiratory rate and heart rate were continuously monitored. Blood pressure was measured at least every 6 hours. ABG was performed after 30 min of starting respiratory support, then, at least every 6 hours in first 24 hours and every 8 hours in next 24 h and as indicated. We used oscillatory NCPAP with PEEP 4-6 cm of water, fraction of inspired oxygen (Fio2) of 0.4, frequency of 3 HZ and amplitude of 3 cm H2O. Maximum permissible PEEP was 8 cm and maximum permissible Fio2 was 0.6. Maximum permissible frequency and amplitude were at the time that we observed oscillation on chest wall (Maximum frequency of 5 HZ and amplitude of 7 cm H2O). Settings was adjusted based on arterial blood gases (ABG) and clinical parameters. Targeted saturation was ≥ 90 %. Intervention 2: Eligible newborns were randomly allocated to the ‘NCPAP’ group. For this purpose, sindi ncpap device (made in Germany) was employed. Using this device, nasal continuous positive airway pressure was given to the patient. INSURE (intubation, surfactant treatment and extubation) technique would have been used if the patient had needed PEEP ≥5 cm/H2o and Fio2 ≥ 40%. The orogastric tube was kept open and suspended from the top wall of the incubator to decompress the stomach. Pulse oximeter saturation, respiratory rate and heart rate were continuously monitored. Blood pressure measured at least every 6 h. ABG was performed after 30 min of starting respiratory support, then, at least every 6 h in first 24 h and every 8 h in next 24 h and as indicated. We used NCPAP with PEEP equal to 4-6 cm of water and fraction of inspired oxygen (Fio2) equal to 0.4. Maximum permissible target was 8 cm for PEEP and 0.6 for Fio2. Settings was adjusted based on arterial blood gases (ABG) and clinical parameters. Targeted saturation was ≥ 90 %. Non-invasive ventilatory failure. Timepoint: During first 72 hours of birth. Method of measurement: A questionnaire was used to investigate the noninvasive ventilation failure within first 72 hours of birth in which data were collected based on observation and ABG. The failure criteria were met by at least 1 of the following: pH ≤ 7.20 and PaCO2 ≥ 60 mm Hg, PaO2 ≤ 50 mm Hg with a fraction of inspired oxygen ≥ 0.6 or respiratory distress increase, recurrent apnea with ≥ 3 episodes per hour associated with bradycardia, a single episode of apnea that required bag and mask ventilation. Milk intolerance rate. Timepoint: Within admission period. Method of measurement: questionnaire. Pneumothorax. Timepoint: Within first 72 h. Method of measurement: CXR. IVH. Timepoint: At the end of first and fourth week or at the time of symptom incidence. Method of measurement: brain sonography. Vice Chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences Approved 2016-06-05 Ethics committee, Ahvaz Jundishapur University of Medical Sciences The main door of Ahvaz Jundishapur University of Medical Sciences and Health Services, opposite the Khuzestan Water and Electricity Authority (five storeys), Golestan highway, Ahvaz Ahvaz Iran (Islamic Republic of)