Umbilical HerniaUHTNCT07735260
Taping for Umbilical Hernia
A study testing Taping of the umbilical hernia in people with Umbilical Hernia, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 months
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- Taping of the umbilical hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2027to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Children's Hospital of Zurich
Zurich, Canton of Zurich, 8008
Hannah R Neeser, MD, +41442494949, hannah.neeser@kispi.uzh.ch
About this study
Official title: Taping for Umbilical Hernia: A Randomized Controlled Trial.
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
- Being tested
- Taping of the umbilical hernia
- Keywords
- Umbilical hernia, Taping, Observation, Medical tape, Strapping, Hernia strapping, Hernia taping, Hernia bracing
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taping of the umbilical herniaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Taping of the umbilical hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6 months of age
Secondary outcomes (6)
Umbilical hernia closure rates at 12 months of age
Measured: At 12 months of age
Occurrence of complications of umbilical hernias within the first 12 months
Measured: Until 12 months of age
Diameter of umbilical fascial defect at all visits
Measured: 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
The Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module is scored from 0 to 100:
- Highest score: 100 = better family functioning and less negative impact on the family.
- Lowest score: 0 = worse family functioning and greater negative impact on the family.
Measured: 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
The Infant Umbilical Score is currently under validation and assesses six aspects, each scored from 1 to 5, giving a total score ranging from 6 to 30. Higher scores indicate greater reviewer satisfaction with the appearance of the infant umbilicus.
Measured: Measured only if and after umbilical fascial closure occurs at either 6 or 12 months
Blinded surgeons assessment of the appearance of the umbilicus after closure of the fascial ring assessed by the Infant Umbilical score
The Infant Umbilical Score is currently under validation and assesses six aspects, each scored from 1 to 5, giving a total score ranging from 6 to 30. Higher scores indicate greater reviewer satisfaction with the appearance of the infant umbilicus.
Measured: at 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ueli Möhrlen, Study chair, University Children's Hospital of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735260
- Sponsor's protocol ID
- 1003
- Other IDs
- BASEC 2025-01453
- Acronym
- UHT
- Status last verified
- Jul 2026
- First submitted
- 18 Feb 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taping for Umbilical Hernia: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07735260
- Acronym / sponsor ID
- UHT / 1003
- Conditions
- Umbilical Hernia
- Keywords
- Umbilical hernia, Taping, Observation, Medical tape, Strapping, Hernia strapping, Hernia taping, Hernia bracing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Taping of the umbilical herniaPatients 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. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
- Legal custodian gives consent to participation in study
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taping of the umbilical herniaThe 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. | Procedure or surgery | Intervention / Taping Group |
Primary outcome
Umbilical hernia closure rates at 6 months
Time frame: at 6 months of age
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.
6 secondary outcomes
Umbilical hernia closure rates at 12 months of age
Time frame: At 12 months of age
Occurrence of complications of umbilical hernias within the first 12 months
Time frame: Until 12 months of age
Diameter of umbilical fascial defect at all visits
Time frame: 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
Time frame: 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
Time frame: Measured only if and after umbilical fascial closure occurs at either 6 or 12 months
Blinded surgeons assessment of the appearance of the umbilicus after closure of the fascial ring assessed by the Infant Umbilical score
Time frame: at 12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ueli Möhrlen study chair
University Children's Hospital of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taping of the umbilical hernia in people with Umbilical Hernia, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah R Neeser, MD (+41442494949, hannah.neeser@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical hernia closure rates at 6 months (time frame: at 6 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.