An interventional study of Taping of the umbilical hernia in Umbilical Hernia, sponsored by University Children's Hospital, Zurich. Not yet recruiting at 1 site in Switzerland. Open to participants aged 1 Month to 3 Months. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University Children's Hospital, Zurich · Not applicable, Interventional, and Treatment
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's planned enrollment of 82 is above the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →University Children's Hospital, Zurich is the lead sponsor of 95 studies on the registry; 23 are open to participants now.
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Infants over 1 month of age and under 3 months of age
Exclusion Criteria:
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.
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
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.
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.
Time frame: at 6 months of age
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
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.
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
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.
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
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.
Time frame: at 12 months of age
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jun 2030, 41 months later.
Of 19 interventional studies with no phase under Hernia, Umbilical, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's planned 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University Children's Hospital, Zurich