Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Pressure Injury; Newborn

Treatments: Other: Standard nursing care; Other: interventional nursing care

Study type: Interventional

Funder types: Other

Identifiers

NCT04293601

LesioniTIN/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: Under 6 months old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Experimental group

Experimental group

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

Treatment:

Other: interventional nursing care

Standard care

Other group

Description:

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

Treatment:

Other: Standard nursing care