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Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04293601
Enrollment
280
Registered
2020-03-03
Start date
2019-12-02
Completion date
2022-05-16
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn, Pressure Injury

Keywords

Cpap, NICU, nasal trauma

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.

Interventions

OTHERinterventional 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

* 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

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Newborns' interventional group are compared with infants born in 2018 who have received standard care interventions according to local protocol.

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Pressure nasal injuriesThrough study completion, an average of 27 monthsEvaluation of the number of pressure nasal injuries

Secondary

MeasureTime frameDescription
Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrenceDetermined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 monthsGestational 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 injuryMeasured at the time of birth and at the time of presentation of nasal injury, an average of 2 monthsNewborns' weight (grams) will be collected from electronical medical records
Duration NCPAP treatmentFrom the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 monthsDuration NCPAP treatment (days) will be collected from electronical medical records
Duration of NICU stayFrom admission in NICU until NICU discharge or transfer in an other ward, an average of 2 monthsDuration of stay in NICU (days) will be collected from electronical medical records

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026