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Does the Pepi splint effectively secure an intravenous drip in hospitalised babies without causing skin injury?

Proof of concept project to determine if the Pepi Splint is effective and does not cause harm in 30 babies > 1000grams

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001335987
Acronym
PEPI
Enrollment
30
Registered
2020-12-11
Start date
2021-01-18
Completion date
2021-04-12
Last updated
2021-01-05

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

Conditions

None listed

Brief summary

Skin injury in hospitalised babies is common. Most babies who are admitted require a peripheral intravenous catheter (drip) for medication and nutrition which are secured to the baby’s limb using a splint and adhesive dressings (elasoplast). Removing the adhesive elastoplast frequently tears the fragile skin, causing pain, increasing the risk of infection and possibly lasting skin damage. The Pepi Splint is made from medical silicone and secures the drip to the baby without the need for elastoplast to be applied to the baby’s skin. We propose that the Pepi Splint will be effective at securing the drip and also acceptable to staff and parents.

Interventions

The Pepi Splint will be applied and secure the PIVC on to the limb (either arm or leg) without the use of adhesive dressings. The splint will remain in place as long as the PIVC is required, which is commonly 12 to 72 hours. The duration of the study will be from the time that Pepi Splint is applied until removal. Therefore the duration of the study will vary for each participant. The effectiveness of the Pepi Splint be measured using data routinely (hourly observations) collected by the beds

The Pepi Splint will be applied and secure the PIVC on to the limb (either arm or leg) without the use of adhesive dressings. The splint will remain in place as long as the PIVC is required, which is commonly 12 to 72 hours. The duration of the study will be from the time that Pepi Splint is applied until removal. Therefore the duration of the study will vary for each participant. The effectiveness of the Pepi Splint be measured using data routinely (hourly observations) collected by the bedside nurse, along with specific data collected about the duration and reasons for removal on a data collection record. Clinical photos will be taken and for later review by the Steering committee. In addition, the parents of babies who participate will be asked to complete a short (one page questionnaire) about what they like and dislike about Pepi Splint (see attached).

Sponsors

Faculty of Health, Victoria University, Wellington
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

Medically fragile babies requiring a PIVC.

Exclusion criteria

Current weight < 1000g Gestational age < 30 completed weeks gestation Any skin conditions preventing the attachment of the Pepi splint Major congenital abnormalities Terminal conditions

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 18, 2026