UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061314 |
|---|---|
| Receipt number | R000070149 |
| Scientific Title | Yuai Okinawa Umbilical Neonatal Granuloma Trial |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/20 00:54:01 |
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Basic information
Public title
The Association Between Umbilical Care and Umbilical Granuloma in Newborns Not Admitted to the NICU: A Randomized Controlled Trial
Acronym
Randomized controlled trial of granuloma inguinale
Scientific Title
Yuai Okinawa Umbilical Neonatal Granuloma Trial
Scientific Title:Acronym
YOUNG Trial
Region
| Japan |
Condition
Condition
umbilical granuloma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of umbilical granuloma at the 1-month checkup
Key secondary outcomes
All patients diagnosed with umbilical granuloma underwent ultrasound examination to evaluate the deep tissue structure of the umbilical fossa and the presence or absence of slow-flow blood. The absence of blood flow was also confirmed after treatment.
As a control group, 15 infants without umbilical granulomas were randomly selected and underwent ultrasound evaluation using the same method.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 5 | 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 sample size
453
Research contact person
Name of lead principal investigator
| 1st name | Eita |
| Middle name | |
| Last name | Tamanaha |
Organization
Social Medical Corporation Yuai-kai, Yuai Medical Center
Division name
pediatrics
Zip code
901-0224
Address
50-212 Yone, Tomigusuku City, Okinawa Prefecture
TEL
0988503811
etamanaha1188@gmail.com
Public contact
Name of contact person
| 1st name | Eita |
| Middle name | |
| Last name | Tamanaha |
Organization
Social Medical Corporation Yuai-kai
Division name
Medical Department
Zip code
901-0224
Address
50-212 Yone, Tomigusuku City, Okinawa Prefecture
TEL
0988503811
Homepage URL
etamanaha1188@gmail.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Eita Tamanaha
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social Medical Corporation Yuai-kai
Address
50-212 Yone, Tomigusuku City, Okinawa Prefecture
Tel
0988503811
etamanaha1188@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
社会医療法人友愛会 友愛医療センター（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
509
Results
At one month, the incidence of umbilical granuloma was 7.3% in the ligation-plus-disinfection group, 8.5% in the disinfection-only group, and 12.2% in the non-disinfection group. Umbilical disinfection was significantly associated with a reduced risk of granuloma formation, whereas vaginal delivery was linked to an increased risk. Doppler ultrasonography revealed a longitudinal blood-flow signal extending from beneath the umbilicus to the granuloma in 91.4% of affected cases
Results date posted
| 2026 | Year | 04 | Month | 20 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
This trial was conducted after receiving ethics committee approval (Approval No. R05R001) and establishing a pre-specified protocol prior to enrolment in May 2023. Registration with the UMIN Clinical Trials Registry was inadvertently delayed due to insufficient awareness of prospective registration requirements at the time of study initiation. No modifications were made to the primary outcome, study design, or analytical methods after data collection. The registered content fully reflects the original study protocol.
Date of the first journal publication of results
Baseline Characteristics
From May 1, 2023, to June 30, 2024, a total of 509 newborns underwent eligibility screening. Of these, 3 cases were transferred to the NICU, 3 cases lacked informed consent, 44 cases refused to participate in the study, 15 cases were excluded because the primary endpoint could not be assessed at the 1-month checkup (all due to non-compliance with disinfection instructions), and 5 cases withdrew after consent was obtained; thus, 439 cases were randomized.
Participant flow
Of the randomized participants, 218 were assigned to the disinfection group and 221 to the non-disinfection group (dry care group). Additionally, retrospective data were collected from 489 cases in the ligation and disinfection group born between April 1, 2022, and April 30, 2023, to serve as a reference cohort. Ultimately, a total of 928 cases, comprising the prospective RCT cohort of 439 cases and the retrospective reference cohort of 489 cases, were included in the per-protocol (PP) analysis.
Adverse events
In this study, no serious umbilical infections were observed in any of the groups (ligation and disinfection group, disinfection group, or no disinfection group). No serious adverse events deemed to be related to umbilical care occurred during the study period, and all interventions were performed safely.
Outcome measures
The analysis included gender, preterm birth or low birth weight, presence or absence of umbilical hernia, presence or absence of umbilical disinfection, mode of delivery (vaginal delivery/cesarean section), and umbilical cord separation 10 days or more as covariates.
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
| 2025 | Year | 07 | Month | 09 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 09 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070149
