Evaluating the effect of probiotics on the outcomes of very preterm infants hospitalized in the neonatalbintensive care unit of Shahid sadoughi hospital,Yazd:a double_blind clinical trial

Evaluating the effect of probiotics on the outcomes of very preterm infants hospitalized in NICU

Double-blind, randomized, placebo-controlled clinical Infants will be randomly placed in two probiotic (treatment) and control groups. Randomization will be done by premature block randomization. The control group will be treated with 5% dextrose. Infants in the treatment group will receive daily 5 drops of probiotics (Pedi Lact drops) of Biotakhmir Company, Tehran-Iran. The drug and placebo will be identical in the coded packages, and the codes based on the randomization table of the shuffled blocks will be provided to the researcher by a designated person.

This study will be conducted in the NICU department of Shahid Sadoughi Hospital in Yazd. Patients will be divided into two groups receiving probiotics and placebo by random permutation block method. Each patient will be identified with a number and the list of numbers of people who should be placed in each group will be given to the nurses, and the participants, researchers, doctors and Data collectors will be unaware of this list.

Inclusion criteria : preterm infants under 32 weeks of age and less than 1500 grams weight, no difference in the type of delivery Exclusion criteria: infant over 32 weeks age,over1500 grams weight, gastrointestinal abnormalities such as various obstructions and Congenital infants who need gastrointestinal surgery (such as: esophageal atresia, duodenum, gastroschisis) Asphyxiated infants.

Intervention group: 30 very preterm infants will receive Pedi Lact probiotic drops orally daily after birth. Control group: 30 very preterm infants will receive 5% dextrose.

Investigating the rate of growth, weight gain and prevention and improvement of necrotizing enterocolitis,Investigating sepsis

Randomization method: In this study, the infants are divided into two groups of 30 people, from these 60 very premature infants hospitalized in the neonatal intensive care unit, by using statistical software 30 infants out of 60 infants were selected completely randomly placed in the treatment group and 30 infants are placed in the placebo group. Infants will be randomly placed in two probiotic (treatment group) and control groups. Randomization will be done by premature block randomization. The control group will be treated with 5% dextrose. Infants in the treatment group will receive daily 5 drops of probiotics (Pedi Lact drops) of Biotakhmir Company, Tehran-Iran. For health purposes, each baby will have a separate supply of probiotics, which will be kept in the refrigerator at 2-8 degrees Celsius. Probiotics will often be placed at room temperature for 10 minutes before daily administration. In the case of placebo (dextrose 5%that will receive 5 drops), it will also be kept in the refrigerator and placed at room temperature before administration. The drug and placebo will be identical in the coded packages, and the codes based on the randomization table of the shuffled blocks will be provided to the researcher by a designated person. Randomization unit: individual Randomization tool: statistical software

In this study, the participants, the principle investigator, the physicians and the data collectors are blinded. The patients who are going to receive the drug or placebo , are determined by numbers and these numbers are given to the head nurse and nurses of surgery department.