Investigating the effect of using antiseptic solutions containing chlorhexidine 2% compared to povidone-Iodine solution in disinfecting the venous catheter placement site in the incidence of catheter associated infections in admitted infantsin the neonatal intensive care unit (NICU)

Comparing the effectiveness of using disinfectant solutions containing 2% chlorhexidine versus povidone-iodine solution to prepare the skin of infants before inserting an intravenous catheter in reducing the risk of catheter-related infections by determining the effect of variables.

This study is designed as a preliminary clinical trial. The total sample size for this study is calculated as 100 infants. A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 110 patients. The rand function of Excel software was used for randomization.

The study was conducted as a pilot, randomized clinical trial on infants hospitalized in the Mahdieh Hospital NICU. Informed consent was obtained from the parents.

Inclusion criteria: Neonates with a gestational age of less than 34 weeks, negative peripheral blood culture and initial CRP, hospitalization for at least 6 days in the NICU, and need for an indwelling intravenous catheter to receive fluids and medication. Exclusion criteria: Lack of consent of the infant's parents to participate in the study, death of the infant before 6 days of hospitalization, positive peripheral blood culture and CRP before catheter insertion, catheter removal before 6 days from the body.

Intervention group, using 2% chlorhexidine solution and control group, using Betadine

Diagnosis at admission, type of delivery, gestational age, birth weight, birth height, birth Apgar, maternal diseases, infant age at catheter insertion, duration of catheter instillation in the infant, type of disinfectant solution, peripheral blood culture and CRP before catheter insertion, catheter culture after removal, peripheral blood culture 6 days after catheter insertion, skin culture immediately after disinfection, occurrence of contact dermatitis

Randomization and assignment of infants to the intervention and control groups is determined using computer-generated random numbers. Even numbers are placed in the intervention group and odd numbers are placed in the control group.

None of the patients, sampling people and interpreters of the tests will be informed about the placement of the patients in the control or intervention group until the publication of the results of the study. The person taking the sample, without knowing the group of the newborns, only prepares the skin culture, peripheral blood and catheter samples and sends them to the laboratory, and the person reviewing the tests, without knowing the placement of the baby in each group, only interprets and reports the results of the tests.

The results will be published in the form of statistical data analyzed by computer software along with explanations. Confidential principles are included in all information.

Access starts 1 month after results are published.

The data will be available only to researchers working in academic and scientific institutions.

The data can be used for reference in future studies.

Please refer to the e-mail of Dr. Golab Bostanchi, responsible for the public response of the study, with the following address. gbos8805@gmail.com

The applicant is required to provide me with a summary of the upcoming research project and to send full academic specifications and academic degree.