Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

May 20, 2022 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Exclusion Criteria:

  • Pre-existing nasal lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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 Names:
  • prospective group
Other: Standard care
Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention"
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
Other Names:
  • retrospective group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Pressure nasal injuries
Time Frame: Through study completion, an average of 27 months
Evaluation of the number of pressure nasal injuries
Through study completion, an average of 27 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence
Time Frame: Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months
Gestational Age (weeks) and postmenstrual age (weeks) will be collected from electronical medical records
Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months
Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury
Time Frame: Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months
Newborns' weight (grams) will be collected from electronical medical records
Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months
Duration NCPAP treatment
Time Frame: From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months
Duration NCPAP treatment (days) will be collected from electronical medical records
From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months
Duration of NICU stay
Time Frame: From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months
Duration of stay in NICU (days) will be collected from electronical medical records
From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Elisa Lagostina, RN, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2019

Primary Completion (Actual)

December 2, 2021

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LesioniTIN/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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