]>
IRCT20190522043672N2 IRCT 2020-10-07 Mashhad University of Medical Sciences Prevention of acute respiratory problems in children ARDS Preventive effect of pentoxifylline in Acute Respiratory Distress Syndrome susceptible children 2020-09-05 anticipated 40 Complete https://irct.ir/trial/50355 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Generating a random allocation sequence using "www.randomization.com" for 40 people, will be done in codes A and B, and the allocation will be hidden using a blurred and numbered sealed envelope, Blinding description: After the codes are prepared and given to the researcher located in Akbar Hospital pharmacy, the patient is randomly placed in one of the groups of intervention or placebo based on the codes.The relevant code is recorded in the CRF form.The patient is introduced to a nurse who is provided with the above form.The delivery of drugs is done by the nurse (therapist) who is unaware of the content of the codes and the type of pills, and in the meantime the evaluator (doctor) who is different from the therapist (nurse) and does not know which drug the patient received and know only the assigned code, makes relevant assessments.To increase the accuracy of the study, all patients prone to ARDS are identified by a specified physician. After recording the history and results, the physician provides the forms to the person who analyzes the data, in the form of a code, and the data analysis is performed without the knowledge of the data analyzer of the type of drug and the content of the codes. 2-3 Acute Respiratory Distress Syndrome. Intervention 1: Intervention group: The suspension prepared from pentoxifylline tablets, which is administered immediately, is given orally at a dose of 20 mg / kg / day in three divided doses for one week. Intervention 2: Control group: In the placebo group, the suspension prepared from the placebo tablet (lactose avicel) is prepared at the time of administration and received in 3 divided doses per day for a week. 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 There is no further information
public Amir Houshang Mohammadpour
Azadi Square, University Campus, Faculty of Pharmacy
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1100 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences scientific Amir Houshang Mohammadpour
Azadi Square, University Campus, Faculty of Pharmacy
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1100 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients at risk for ARDS who have lipsā‰„4 based on lung injury prediction score (lips) and do not complete the ARDS diagnosis criteria 1 month 18 years Both Acute prenatal hypoxemia such as premature infant-related lung disease, prenatal lung injury (such as Meconium Aspiration Syndrome, pneumonia, and sepsis occurring during childbirth) are excluded. A disease that inevitably leads to death and is contrary to life Children with adrenal insufficiency Inflammation of blood vessels Patients with intolerance to methylxanthine and pentoxifylline J80 Acute respiratory distress syndrome Treatment - Drugs Placebo Intervention group: The suspension prepared from pentoxifylline tablets, which is administered immediately, is given orally at a dose of 20 mg / kg / day in three divided doses for one week. Control group: In the placebo group, the suspension prepared from the placebo tablet (lactose avicel) is prepared at the time of administration and received in 3 divided doses per day for a week. Incidence of acute respiratory distress syndrome. Timepoint: During the study and at the end of the study. Method of measurement: Diagnosis based on criteria for diagnosing acute respiratory distress syndrome. Heart rate. Timepoint: At baseline and during the receive of the medication. Method of measurement: Cardiac Monitoring. Respiration rate. Timepoint: At baseline and during the receive of the medication. Method of measurement: Cardiac Monitoring. Continuous pulse oximetry. Timepoint: At baseline and during the receive of the medication. Method of measurement: Capnography. Blood gas factors. Timepoint: At baseline and during the receive of the medication. Method of measurement: Capnography. Blood pressure. Timepoint: At baseline and during the receive of the medication. Method of measurement: Cardiac Monitoring. Mashhad University of Medical Sciences Approved 2020-07-04 Ethics committee of Mashhad University of Medical Sciences Shahid Kaveh Blvd., in front of Shahid Kaveh 14, Akbar Hospital, PICU Mashhad Razavi Khorasan Iran (Islamic Republic of)