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IRCT20260108068588N1 IRCT 2026-02-10 Shahid Beheshti University of Medical Sciences Comparison of the effects of chlorhexidine 2% and betadine in disinfecting the insertion site of indwelling venous catheters in neonates admitted to the neonatal intensive care unit during the hospitalization period. 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) 2026-02-11 anticipated 100 Complete https://irct.ir/trial/88892 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: -, Randomization description: 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, Blinding description: 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. N/A Catheter-related bloodstream infections. Intervention 1: Intervention group: Infants who received 2% chlorhexidine solution to disinfect the intravenous catheter insertion site. Intervention 2: Control group: Use of povidone iodine solution to disinfect the catheter insertion site. Yes - There is a plan to make this available What will be shared: 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. When: Access starts 1 month after results are published. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: The data can be used for reference in future studies. Where to obtain: 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 How to obtain: The applicant is required to provide me with a summary of the upcoming research project and to send full academic specifications and academic degree. Comments:
public Golab Bostanchi
Mahdieh Hospital, Rajab-nia St., Fadaeeian-e-islam ave,. Shush Square., Tehran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 gbos8805@gmail.com Shahid Beheshti University of Medical Sciences scientific Naeemeh Taslimi Taleghani
Mahdieh Hospital, Rajab-nia St., Fadaeeian-e-islam ave,. Shush Square., Tehran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 naeemetaslimi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Newborns admitted to the neonatal intensive care unit Newborns requiring indwelling intravenous catheters during their stay in the neonatal intensive care unit Preterm newborns no limit no limit Both Parents' lack of consent to the infant's inclusion in the study No need for hospitalization for more than 3 days in the neonatal intensive care unit Evidence of sepsis before intravenous catheter placement in the neonate B99 Other and unspecified infectious diseases N/A N/A Intervention group: Infants who received 2% chlorhexidine solution to disinfect the intravenous catheter insertion site. Control group: Use of povidone iodine solution to disinfect the catheter insertion site. Gestational age. Timepoint: Weeks from fertilization. Method of measurement: Pregnancy Calendar. Durability of the catheter in the infant's body. Timepoint: Days with a catheter in the body. Method of measurement: Difference between catheter insertion and removal dates. Peripheral blood culture. Timepoint: 6 days after catheter insertion. Method of measurement: Blood sample. Catheter culture after removal. Timepoint: After catheter removal. Method of measurement: Peripheral blood culture tests, catheter culture, skin culture. Skin culture immediately after disinfection. Timepoint: Immediately after disinfection. Method of measurement: A sterile cotton swab is applied to the disinfected skin and sent for culture. Contact dermatitis. Timepoint: Within 1 to 5 days after disinfection. Method of measurement: Observation. Shahid Beheshti University of Medical Sciences Approved 2026-01-27 Ethics committee of Shahid Beheshti University of Medical Sciences 6th floor, Shahid Beheshti University of Medical Sciences and Health Services, Shahid Beheshti University of Medical Sciences and Health Care Services, Shahid Chamran Highway, Yemen St., 6th Floor Tehran Tehran Iran (Islamic Republic of)