Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2022-05-16

Brief Summary

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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.

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Detailed Description

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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

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Newborn Pressure Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Newborns' interventional group are compared with infants born in 2018 who have received standard care interventions according to local protocol.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental group

All enrolled neonates will receive interventions that will be performed with different frequency and method according to newborns' risk factors, as well as the following standard interventions received by control group's newborns:

* appropriate use of hydrocolloid, headbands, masks and prongs
* frequently assess skin integrity
* humidity and heat gases

Group Type EXPERIMENTAL

interventional nursing care

Intervention Type OTHER

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

Standard care

Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention"

Group Type OTHER

Standard nursing care

Intervention Type OTHER

* 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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prospective group retrospective group

Eligibility Criteria

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Inclusion Criteria

* Informed consent signed from both parents or legally authorized representative
* Infants receiving noninvasive respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) or Synchronized Nasal Intermittent Positive Pressure Ventilation (SNIPPV)