Pressure Injuries' Prevention in Newborn Infants Admitted to NICU
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 02/16/2020 |
| Estimated Enrollment Submitted: | 02/27/2020 |
| First Posted: | 03/02/2020 |
| Last Update Submitted: | 02/27/2020 |
| Last Update Posted: | 03/02/2020 |
| Actual Study Start Date: | 12/01/2019 |
| Estimated Primary Completion Date: | 12/01/2021 |
| Estimated Study Completion Date: | 03/01/2022 |
Condition or disease
Intervention/treatment
Other: Experimental group
Other: Standard care
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Experimental group 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: Experimental group 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 |
| Other: Standard care Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention" | Other: Standard care 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 |
Eligibility Criteria
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Number of Pressure nasal injuries [Through study completion, an average of 27 months]
Secondary Outcome Measures
1. 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]
2. 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]
3. Duration NCPAP treatment [From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months]
4. Duration of NICU stay [From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months]
