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Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Primary Purpose

Newborn, Pressure Injury

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
interventional nursing care
Standard nursing care
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Newborn focused on measuring Cpap, NICU, nasal trauma

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Standard care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Pressure nasal injuries
Evaluation of the number of pressure nasal injuries

Secondary Outcome Measures

Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence
Gestational Age (weeks) and postmenstrual age (weeks) will be collected from electronical medical records
Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury
Newborns' weight (grams) will be collected from electronical medical records
Duration NCPAP treatment
Duration NCPAP treatment (days) will be collected from electronical medical records
Duration of NICU stay
Duration of stay in NICU (days) will be collected from electronical medical records

Full Information

First Posted
February 17, 2020
Last Updated
May 20, 2022
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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1. Study Identification

Unique Protocol Identification Number
NCT04293601
Brief Title
Pressure Injuries' Prevention in Newborn Infants Admitted to NICU
Official Title
Pressure Injuries' Prevention in Newborn Infants Admitted to NICU Receiving Noninvasive Respiratory Support With Nasal Continuous Positive Airway Pressure (NCPAP)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn, Pressure Injury
Keywords
Cpap, NICU, nasal trauma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Newborns' interventional group are compared with infants born in 2018 who have received standard care interventions according to local protocol.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard care
Arm Type
Other
Arm Description
Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention"
Intervention Type
Other
Intervention Name(s)
interventional nursing care
Other Intervention Name(s)
prospective group
Intervention Description
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
Intervention Name(s)
Standard nursing care
Other Intervention Name(s)
retrospective group
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Pressure nasal injuries
Description
Evaluation of the number of pressure nasal injuries
Time Frame
Through study completion, an average of 27 months
Secondary Outcome Measure Information:
Title
Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence
Description
Gestational Age (weeks) and postmenstrual age (weeks) will be collected from electronical medical records
Time Frame
Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months
Title
Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury
Description
Newborns' weight (grams) will be collected from electronical medical records
Time Frame
Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months
Title
Duration NCPAP treatment
Description
Duration NCPAP treatment (days) will be collected from electronical medical records
Time Frame
From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months
Title
Duration of NICU stay
Description
Duration of stay in NICU (days) will be collected from electronical medical records
Time Frame
From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Lagostina, RN
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
Facility Information:
Facility Name
NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27666491
Citation
Chen CY, Chou AK, Chen YL, Chou HC, Tsao PN, Hsieh WS. Quality Improvement of Nasal Continuous Positive Airway Pressure Therapy in Neonatal Intensive Care Unit. Pediatr Neonatol. 2017 Jun;58(3):229-235. doi: 10.1016/j.pedneo.2016.04.005. Epub 2016 Jul 26.
Results Reference
background
PubMed Identifier
28970314
Citation
Imbulana DI, Manley BJ, Dawson JA, Davis PG, Owen LS. Nasal injury in preterm infants receiving non-invasive respiratory support: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F29-F35. doi: 10.1136/archdischild-2017-313418. Epub 2017 Sep 28.
Results Reference
background
PubMed Identifier
23173614
Citation
Maruccia M, Fanelli B, Ruggieri M, Onesti MG. Necrosis of the columella associated with nasal continuous positive airway pressure in a preterm infant. Int Wound J. 2014 Jun;11(3):335-6. doi: 10.1111/j.1742-481X.2012.01121.x. Epub 2012 Nov 22. No abstract available.
Results Reference
background
PubMed Identifier
28914355
Citation
Khan J, Sundaram V, Murki S, Bhatti A, Saini SS, Kumar P. Nasal injury and comfort with jet versus bubble continuous positive airway pressure delivery systems in preterm infants with respiratory distress. Eur J Pediatr. 2017 Dec;176(12):1629-1635. doi: 10.1007/s00431-017-3016-7. Epub 2017 Sep 15.
Results Reference
background
Citation
Arshadi M, Jabraeili M, Karimipoor S et al. The Efficacy of a Protocolized Nursing Care on Nasal Skin Breakdown in Preterm Neonates Receiving Nasal Continuous Positive Airway Pressure. International Journal of Pediatrics. 2017;5(1):4217-25.
Results Reference
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Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

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