Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Study Overview
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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.

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.

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

Conditions
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Newborn, Pressure Injury

Intervention / Treatment
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* Other: interventional nursing care
* Other: Standard nursing care


Participation Criteria
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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) Exclusion Criteria: Pre-existing nasal lesion

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 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<br>* Other names: prospective group;|
| Other: Standard care<br>Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the assigned intervention | Other: Standard nursing care<br>* 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<br>* Other names: retrospective group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pressure nasal injuries | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cpap, NICU, nasal trauma