Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

NCT04293601 | Completed

• 1 other identifier: LesioniTIN/2019
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn; Pressure Injury

Keywords

Cpap; NICU; nasal trauma

Outcome Measures

Primary Outcomes (1)

• Number of Pressure nasal injuries

  Evaluation of the number of pressure nasal injuries

  Through study completion, an average of 27 months

Secondary Outcomes (4)

• 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

• 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

• Duration NCPAP treatment

  From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months

• Duration of NICU stay

  From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Standard care

OTHER

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

Other: Standard nursing care

Interventions

interventional nursing care OTHER

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

Also known as: prospective group

Experimental group

Standard nursing care OTHER

* 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

Also known as: retrospective group

Standard care

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Pre-existing nasal lesion

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (5)

• Chen CY, Chou AK, Chen YL, Chou HC, Tsao PN, Hsieh WS. Quality Improvement of Nasal Continuous Positive Airway Pressure Therapy in Neonatal Intensive Care Unit. Pediatr Neonatol. 2017 Jun;58(3):229-235. doi: 10.1016/j.pedneo.2016.04.005. Epub 2016 Jul 26.

  PMID: 27666491 BACKGROUND

• Imbulana DI, Manley BJ, Dawson JA, Davis PG, Owen LS. Nasal injury in preterm infants receiving non-invasive respiratory support: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F29-F35. doi: 10.1136/archdischild-2017-313418. Epub 2017 Sep 28.

  PMID: 28970314 BACKGROUND

• Maruccia M, Fanelli B, Ruggieri M, Onesti MG. Necrosis of the columella associated with nasal continuous positive airway pressure in a preterm infant. Int Wound J. 2014 Jun;11(3):335-6. doi: 10.1111/j.1742-481X.2012.01121.x. Epub 2012 Nov 22. No abstract available.

  PMID: 23173614 BACKGROUND

• Khan J, Sundaram V, Murki S, Bhatti A, Saini SS, Kumar P. Nasal injury and comfort with jet versus bubble continuous positive airway pressure delivery systems in preterm infants with respiratory distress. Eur J Pediatr. 2017 Dec;176(12):1629-1635. doi: 10.1007/s00431-017-3016-7. Epub 2017 Sep 15.

  PMID: 28914355 BACKGROUND

• Arshadi M, Jabraeili M, Karimipoor S et al. The Efficacy of a Protocolized Nursing Care on Nasal Skin Breakdown in Preterm Neonates Receiving Nasal Continuous Positive Airway Pressure. International Journal of Pediatrics. 2017;5(1):4217-25.

  BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elisa Lagostina, RN

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: March 3, 2020
• Study Start: December 2, 2019
• Primary Completion: December 2, 2021
• Study Completion: May 16, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)