Tokyo, April 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061314) titled 'The Association Between Umbilical Care and Umbilical Granuloma in Newborns Not Admitted to the NICU: A Randomized Controlled Trial' on April 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - other

Condition: Condition - umbilical granuloma Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - in this study, newborns were randomly assigned to either a group receiving only dry care without postnatal umbilical care or a group receiving conventional disinfection, and the incidence of umbilical granuloma and the rate of complications such as periumbilical inflammation at the one-month checkup were compared. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The umbilical cord clips were removed by the second day of life, once the umbilical stump had dried sufficiently. Infants were then assigned to a group (the disinfection group) in which the area around the umbilicus was disinfected once daily with a cotton swab soaked in ethanol disinfectant after the clip was removed. In the disinfection group, medical-grade ethanol was used for disinfection during hospitalization. After discharge, the disinfection group was provided with disinfectant ethanol solution and instructed to disinfect the umbilical area once a day after bathing until the 1-month checkup. Interventions/Control_2 - Participants were assigned to the no-disinfection group, in which moisture was wiped away with a cotton swab without using ethanol based antiseptic solution. After discharge, the no-disinfection group was instructed to perform dry care removing only moisture from the umbilical cord once a day after bathing until the one-month follow up visit.

Eligibility: Age-lower limit - 1 days-old = Gender - Male and Female Key inclusion criteria - We explained the procedure to parents both in writing and verbally, and confirmed their compliance during the one-month checkup. In addition, nurses explained and verified the disinfection procedure with the parents to ensure there was no information bias. The diagnosis of umbilical granuloma was made by four pediatric specialists who conducted the one-month checkup. Diagnostic criteria were standardized in advance, and the clinical evaluation was conducted after confirming diagnostic consistency. Umbilical granuloma was defined as cases in which red granulation tissue protruded from the umbilical fossa and exudate was observed. Key exclusion criteria - Cases transferred to the NICU; cases where informed consent was not obtained; cases where participants refused to participate in the study; cases excluded because primary outcome measures could not be assessed at the 1-month follow-up; and cases involving non-compliance with disinfection instructions or withdrawal of consent after it had been obtained Target Size - 453

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 04 Month 07 Day Date of IRB - 2023 Year 04 Month 14 Day Anticipated trial start date - 2023 Year 05 Month 01 Day Last follow-up date - 2024 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070149

Disclaimer: Curated by HT Syndication.