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Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

NCT04293601 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2022-05-23

No results posted yet for this study

Summary

Nasal Continuous Positive Airway Pressure (NCPAP) is a respiratory support for neonates with Respiratory Distress Syndrome (RDS) and represents the gold standard for RDS treatment in many Neonatal Intensive Care Units (NICU). Respiratory supports providing Synchronized Nasal Intermittent Positive Pressure Ventilation may further enhance the success of non-invasive respiratory support.

The most significant risk factor associated to NCPAP management is nasal trauma. Nasal injuries represent a source of pain and discomfort for infants. In some cases, they could become a site of infection and cause functional, cosmetic, long term outcomes as erythema or necrosis of the columella nasi.

The aim of this study is to evaluate the effectiveness of nursing interventions to reduce the incidence of pressure injuries during NCPAP support in infants admitted to NICU.

It is hypothesized that implementation of some preventive interventions could improve nursing care quality and reduce nasal pressure injuries.

Conditions

  • Newborn
  • Pressure Injury

Interventions

OTHER

interventional nursing care

The infants enrolled will receive different intervention according to a defined risk factor level: "Low": * NCPAP duration \< 48 hours (h) * Gestational Age (GA) \> 32 weeks (wks) * Current weight \> 1500 g Interventions: * alternating mask or nasal prongs once per shift * skin assessment (excoriation, erythema or skin breakdown) once per shift "Medium": * NCPAP duration from 48 to 72 h * GA from 32 to 28 wks * Current weight from 1500 to 1000 g Interventions: * alternating mask or nasal prongs twice per shift * skin assessment (excoriation, erythema or skin breakdown) twice per shift * repositioning of device once per shift "High": * NCPAP duration \> 72 h * GA \< 28 wks * Current weight \< 1000 g Interventions: * alternating mask or nasal prongs twice per shift * skin assessment (excoriation, erythema or skin breakdown) every 3 h per shift * repositioning of device every 3 h per shift

OTHER

Standard nursing care

* Use of hydrocolloid as nasal barrier dressing * Appropriate size of headbands, indicated by production company * Appropriate size of mask or binasal prongs, indicated by production company * Frequently assess skin integrity, every 4 hours * Replace hydrocolloid if it's dirty or displaced * Humidity and heat gases

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Elisa Lagostina, RN · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2021-12-02
Completion
2022-05-16

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293601 on ClinicalTrials.gov