Taping for Umbilical Hernia

NCT07735260 | Not Yet Recruiting DMC

• 2 other identifiers: 1003BASEC 2025-01453
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Umbilical hernias in infants are very common and in most cases disappear on their own by school age. If this does not happen, surgery may be necessary. Until then, the umbilical hernia is usually only observed and not treated. This approach is currently considered the medical standard. With this study, the investigators want to find out whether taping the umbilical hernia causes it to disappear more quickly. The investigators also want to know whether taping leads to less frequent protruding belly buttons (fewer "outies") and whether taping can cause a change in the quality of life of the parents. The investigatorsare therefore planning a study in which they will randomly divide patients into groups (observation versus taping) and examine the infants at 6 and 12 months of age. In addition to our physical examinations, the parents will each fill out a questionnaire about any stress they may be experiencing due to the umbilical hernia.

Conditions

Umbilical Hernia

Keywords

Umbilical hernia; Taping; Observation; Medical tape; Strapping; Hernia strapping; Hernia taping; Hernia bracing

Outcome Measures

Primary Outcomes (1)

• Umbilical hernia closure rates at 6 months

  The primary objective is to show that umbilical hernia closure rates at 6 months of age in infants with umbilical hernias undergoing umbilical taping are increased compared to the control group without taping.

  at 6 months of age

Secondary Outcomes (6)

• Umbilical hernia closure rates at 12 months of age

  At 12 months of age

• Occurrence of complications of umbilical hernias within the first 12 months

  Until 12 months of age

• Diameter of umbilical fascial defect at all visits

  Measured at each visit (first visit, at 6 months and at 12 months of age)

• Parental health-related quality of life assessed by the Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module

  Measured at each visit (first visit, at 6 months and at 12 months of age)

• Parental satisfaction of the appearance of the umbilicus after closure of the fascial ring assessed by the Infant Umbilical score

  Measured only if and after umbilical fascial closure occurs at either 6 or 12 months

Study Arms (2)

Control Group

NO INTERVENTION

Patients in this group will be observed and monitored twice after randomization during the study period. This is the current medical standard for infants with an umbilical hernia.

Intervention / Taping Group

EXPERIMENTAL

Patients in this group receive taping of their umbilical hernia by their parents/caretakers at home and be seen twice after randomization during the study period.

Procedure: Taping of the umbilical hernia

Interventions

Taping of the umbilical hernia PROCEDURE

The study intervention is taping of the umbilical hernia. Patients parents of the treatment group shall be instructed by our physiotherapist on how to perform umbilical hernia taping. A parent information sheet on the standardized application of taping will be provided. Umbilical hernia taping involves reducing the prolapse beneath the level of the abdominal wall and applying multiple medical tapes to apply long-lasting and light pressure on the umbilicus as to prevent the hernia from protruding.

Intervention / Taping Group

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with protruding umbilical hernias with a visible protrusion above the level of the abdominal wall
• Infants over 1 month of age and under 3 months of age
• If the patient is born prematurely (\<37 0/7 weeks) it has to also be at least 4 weeks old AND over 32 weeks postmenstrual age (see below) and younger than 52 weeks postmenstrual age (i.e. 3 months of corrected age)
• Legal custodian gives consent to participation in study

You may not qualify if:

• Umbilical abnormalities, such as stump still in place, continuing wet umbilicus or umbilical granuloma
• Premature infants younger than 32 weeks of postmenstrual age
• Patients with known underlying skin diseases in whom taping may cause extensive skin damage, such as Epidermolysis bullosa
• Patients after suture-less closure of gastroschisis
• Patients in whom the umbilical tapes cannot be positioned as per study protocol, e.g. in patients with intestinal ostomies.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital of Zurich

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ueli Möhrlen

  University Children's Hospital of Zurich

  STUDY CHAIR

Central Study Contacts

Hannah R Neeser, MD

CONTACT

+41442494949; hannah.neeser@kispi.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

CH (1)