Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Not Applicable

Completed

• Conditions: Newborn; Pressure Injury
• Interventions: Other: Standard nursing care; Other: interventional nursing care

• Registration Number: NCT04293601
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Primary Completion: 2021-12-02
• Status Verified: 2022-05
• Study Completion: 2022-05-16
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard care	Standard nursing care	Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention"
Experimental group	interventional nursing care	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

Primary Outcome Measures

Name	Time	Method
Number of Pressure nasal injuries	Through study completion, an average of 27 months	Evaluation of the number of pressure nasal injuries

Secondary Outcome Measures

Name	Time	Method
Duration NCPAP treatment	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
Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence	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
Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury	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
Duration of NICU stay	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

Trial Locations

Locations (1)

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy