Evaluation of the effect of vitamin E in the prevention of acute renal failure in infants weighing more than 1000 admitted to the neonatal intensive care unit

Evaluation of the effect of vitamin E in the prevention of acute renal failure in infants weighing more than 1000 admitted to the neonatal intensive care unit in Arak Talghani Hospital

The clinical trial is in phase 3 with control group and random allocation in two groups, with parallel groups, double blind strains on 150 patients. For randomization, the easy randomization method will be used using the beads inside the envelope.

This study will be conducted as a clinical trial in the neonatal intensive care unit at Amirkabir and Taleghani Hospital in Arak, and the study will be conducted in a double-blind manner in which caregivers and companions are blinded to the study. Infants who are hospitalized in the intensive care unit and do not have contraindications to vitamin E intake will be considered as the study group. In this study, 150 infants who meet the inclusion criteria will be selected. Patients will be randomly assigned into two groups, 75 infants will be in the vitamin E group and 75 children will be in the control group. The treatment continued for 6 days and the creatinine level was recorded before and after the treatment.

Infants hospitalized in the neonatal intensive care unit weighing more than 1000 grams and not having any congenital or chromosomal abnormalities are considered as the study group, and infants with vitamin E sensitivity, any contraindications to vitamin E consumption, and lack of consent to participate in the study will be excluded from the study.

In the intervention group, vitamin E is administered at the dose of 3 units per kilogram of the baby's weight per day. This medicine is manufactured by Behsa Company and is given to the neonates for 6 days. In the control group, the same placebo will be used.

Creatinine level

Randomization type will be simple randomization. 150 envelopes of the same shape and size with black and white inner beads will be selected. Then these 150 envelopes are mixed. When the patient visits according to the conditions of entering the study, the researcher will take out an envelope, and if the inner bead is black, the patient will enter the control group, and if the bead is white, the patient will enter the intervention group. This envelope will be stored in another box. This will be repeated 150 times.

People from the research team who are responsible for nursing and prescribing drugs to patients will not know about the groups. Also after consent form approval, neither patients nor their companions were informed about patients group of control and intervention. Also in control group we will use placebo.