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IRCT20230326057775N1 IRCT 2023-10-09 Yazd University of Medical Sciences Use of less invasive method in administering surfactant A comparative study of the effectiveness of administering surfactant by a (LISA) with a standard (invasive) method in premature infants with RDS 2022-08-05 anticipated 120 Complete https://irct.ir/trial/72360 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Infants who meet the criteria for entering the study, using the random number table and PASS15 software, the numbers of the samples are announced to the researcher by the statistical consultant, and based on that, the sample is placed in one of the study groups. Randomization of the samples in the two groups under investigation is divided into two groups using the Random allocation software and using the random permutation block method, Blinding description: All infants are under n-cpap ventilation before surfactant injection. Only the surfactant injection method will be different in the two groups, and the researcher responsible for implementing the plan (neonatal specialist flu) will be aware of the injection method along with the assistant nurse. In infants who underwent LISA. During surfactant injection, they are subjected to oxygen therapy by n-cpap method continuously. In the invasive method, after intubation and surfactant injection, the patient's tracheal tube is removed and then he undergoes n-cpap again. All other tasks are the same in both groups. The only difference between the two groups is in the surfactant administration method. 3 Respiratory distress syndrome. Intervention 1: Intervention group: In the intervention group, the less invasive method (LISA) is used for surfactant injection, and the endotracheal tube, which is an invasive method, is not used. In the LISA method, direct laryngoscopy is first performed and then an f5 NG-tube is inserted to the desired depth with Magill forceps. Intervention 2: Control group: (control group or standard treatment group) In this group, the conventional invasive method with an endotracheal tube is used for surfactant injection. First, the baby is intubated, then the surfactant solution is drawn with a dose of 200 mg/kg in a 5-10 cc syringe that has been prepared in advance. and then it is injected into the tracheal tube within two minutes. 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 The data and identity of the participants are confidential. However, it is possible to provide access to data and other protocols for other researchers, as well as for the ethics committee and other relevant institutions, by sending an email to the responsible author. Other data and statistical analysis map and consent letters are at the disposal of the main researcher, which will be emailed to the requester if necessary.
public Mahdieh Saberi Anari
NICU of Shahid Sadoughi Hospital, Ebne Sina Ave., Shahid Ghandi Blvd., Safaeyeh, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3183 3734 dr.mahdiehsaberi@gmail.com Yazd University of Medical Sciences scientific Mohamad hosein lookzade
Shahid Sadoughi Hospital, Ebne Sina Ave., Shahid Ghandi Blvd., Safaeyeh, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3183 3734 drlookzadeh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) All babies with GA = 28-34 weeks Have RDS (respiratory score greater than 5) CPAP pressure > 6 cm H2O 1 day 1 day Both Babies with chromosomal abnormalities Major congenital anomalies Oxygen (FiO2) > 40% P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices Intervention group: In the intervention group, the less invasive method (LISA) is used for surfactant injection, and the endotracheal tube, which is an invasive method, is not used. In the LISA method, direct laryngoscopy is first performed and then an f5 NG-tube is inserted to the desired depth with Magill forceps. Control group: (control group or standard treatment group) In this group, the conventional invasive method with an endotracheal tube is used for surfactant injection. First, the baby is intubated, then the surfactant solution is drawn with a dose of 200 mg/kg in a 5-10 cc syringe that has been prepared in advance. and then it is injected into the tracheal tube within two minutes. The frequency of surfactant injection. Timepoint: Depending on the need for surfactant, every few hours or every few days. Method of measurement: Number of injections. Time to start supplemental feeding. Timepoint: How many days after birth did the feeding start?. Method of measurement: Day. Duration of mechanical ventilation. Timepoint: day. Method of measurement: Based on the number of days required for ventilation. Incidence of Retinopathy of prematurity (ROP). Timepoint: Initial screening will be done as soon as possible and followed up for up to 3 months. Method of measurement: Eye examination by a retina specialist. Incidence of bronchopulmonary dysplasia (BPD). Timepoint: After 28 days, it is checked daily. Method of measurement: Based on oxygen requirement and ventilator dependence. Yazd University of Medical Sciences Approved 2022-01-11 Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd WJPN office, Mother and Newborn Health Research Center, Shahid Sadoughi Hospital, Ebne Sina Ave., Shahid Ghandi Blvd., Safaeyeh, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)