Evidence-Based Nursing Infant, Newborn
Conditions
Interventions
This is a two-arm randomized controlled clinical trial. The total sample size was calculated at 728 procedures, divided into intervention and control groups across the two types of procedures included
thus, blinding will be maintained for this outcome variable. Statistical analysis of the data will be performed in a blinded manner. Procedures will be carried out according to the institution&apos
s routine frequency (access dressing change: 24 hours after insertion, then every 7 days, or changed/removed as needed based on assessment
endotracheal tube fixation change/removal: as needed based on integrity and safety assessments, or in the event of extubation). For the purposes of the study, the proce
Sponsors
Universidade Federal do Paraná - UFPR
Complexo do Hospital de Clínicas da Universidade Federal do Paraná - HCUFPR
Eligibility
Age
No minimum to 29 Days
Inclusion criteria
Inclusion criteria: Neonates (up to 29 days of life, and considering corrected age for premature infants) of both sexes using endotracheal tube (ETT) fixation adhesive;Neonates of both sexes using polyurethane adhesive dressing on peripherally inserted central venous catheter (PICC)
Exclusion criteria
Exclusion criteria: Neonates presenting previous skin alteration at the adhesive fixation site (ex: injury, erythema, urticaria, hyperpigmentation, hemangiomas, etc.); presenting any type of reaction to the dressing removal product;teing under phototherapy; presenting a confirmed diagnosis or suspicion of congenital epithelial syndromes; other orotracheal tube fixations different from those described in the protocol;anatomical alterations in the lip and chin region (e.g., cleft lip); presenting fluid or extravasation of infusion content at the insertion site of the peripherally inserted central venous catheter at the time of the intervention; legal guardian under 18 years of age or changing or removing the endotracheal tube fixation or PICC dressing in an emergency (non-elective) situation, for example: accidental extubation, accidental traction of the devices, clinical complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the incidence rate of adhesive-related skin lesions will be significantly lower in the intervention group compared to the control group. This was verified by direct skin assessment after the procedure and by evaluation of the photographic record of the skin (blind assessment). | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the intervention group will show a significantly lower procedure-related pain score compared to the control group. Pain: Verified by applying the Neonatal Infant Pain Scale (NIPS, translated and validated for Brazil) before and during the procedure. ;It is expected that the severity of procedure-related injuries will be significantly lower in the intervention group compared to the control group. Injury severity: verified by direct skin assessment after the procedure and evaluation of the photographic record of the skin by a specialist (blind assessment). | — |
Countries
BR
Contacts
Public ContactKarina dos Reis
Universidade Federal do Paraná - UFPR
Outcome results
None listed