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The Association Between Umbilical Care and Umbilical Granuloma in Newborns Not Admitted to the NICU: A Randomized Controlled Trial

Yuai Okinawa Umbilical Neonatal Granuloma Trial - YOUNG Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061314
Enrollment
453
Registered
2026-04-20
Start date
2023-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

umbilical granuloma

Interventions

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 aroun

Sponsors

other
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Presence or absence of umbilical granuloma at the 1-month checkup

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactEita Tamanaha

Social Medical Corporation Yuai-kai Medical Department

etamanaha1188@gmail.com0988503811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026