Preventive effect of pentoxifylline in Acute Respiratory Distress Syndrome susceptible children

Determining the effect of prophylactic administration of pentoxifylline in children prone to Acute Respiratory Distress Syndrome (ARDS)

randomized double blind clinical trial on 40 patients. A random number table is used for randomization.

The preventive effect of pentoxifylline on the incidence of ARDS in children admitted to the PICU ward with risk factors for this disease will be investigated in Akbar Pediatric Hospital in Mashhad.In forty patients diagnosed by a pediatric intensive care specialist who have completed the entry and exit requirements, the informed consent form is signed by the guardian and entered into the study. Patients are divided into control and intervention groups based on the type of drug received using a random number table. The intervention group receives a solution of pentoxifylline for one week and the placebo group receives a placebo (water) for one week.Blinding: patient, doctor, nurse, analyzer

All patients at risk for ARDS who have lips≥4 based on lung injury prediction score (lips) and do not complete the ARDS diagnosis criterion will be included in the study. Children with acute perinatal hypoxemia, children with diseases that will inevitably die, children with adrenal insufficiency, and vascular inflammation are not included in the study.

In the intervention group, patients received a suspension prepared from pentoxifylline tablets (tablets are administered immediately and suspended in water) at a dose of 20 mg / kg / day in three divided doses for one week. In the placebo group, patients receive a suspension prepared from a placebo tablet (a mixture of avicel-lactose) as as the previous method at the time of administration and in 3 separate doses per day for one week.

Incidence of acute respiratory distress syndrome

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.

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.