NCT04293601

Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Pressure Injuries' Prevention in Newborn Infants Admitted to NICU Receiving Noninvasive Respiratory Support With Nasal Continuous Positive Airway Pressure (NCPAP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Previous studies highlighted that nasal trauma, due to NCPAP support, is caused by the following risk factors: * Very Low birth weight (\< 1500 g) * Gestational age \< 32 weeks * NCPAP duration \> 5 days * NICU stay of \> 14 days However, previous studies results are mixed regarding factors affecting nasal injuries in neonates supported with NCPAP. Interventions indicated as protective are: * Appropriate size of mask or nasal prongs and headbands * Use of hydrocolloid as nasal barrier dressing * A frequent alternation of the NCPAP device (nasal prongs or mask) * A frequent assessment of skin integrity In this study a cohort of neonates (experimental group) will be prospectively enrolled and compared to a cohort of neonates born in 2018 (retrospective group) with similar characteristics. The NICU clinical procedures for skin integrity are similar for both cohorts but the experimental group will receive them with different frequency and modality based on previously defined risk factors that each newborn present. Hence, aim of this study is: \- To asses the effectiveness of specific nursing care interventions on the incidence of pressure injuries due to NCPAP support in neonates admitted to NICU.

Conditions

• Newborn
• Pressure Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-12-02
• Completion: 2022-05-16
• First posted: 2020-03-03
• Last updated: 2022-05-23

Locations

1 site across 1 country: Italy