Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293601
• Other study ID #: LesioniTIN/2019
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: May 16, 2022

Study information

• Verified date: May 2022
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: May 16, 2022
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Newborn
• Pressure Injury
• Wounds and Injuries

Intervention

Other:
• interventional 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
• Standard nursing 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

Locations

Country	Name	City	State
Italy	NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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.

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Pressure nasal injuries	Evaluation of the number of pressure nasal injuries	Through study completion, an average of 27 months
Secondary	Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence	Gestational Age (weeks) and postmenstrual age (weeks) will be collected from electronical medical records	Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months
Secondary	Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury	Newborns' weight (grams) will be collected from electronical medical records	Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months
Secondary	Duration NCPAP treatment	Duration NCPAP treatment (days) will be collected from electronical medical records	From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months
Secondary	Duration of NICU stay	Duration of stay in NICU (days) will be collected from electronical medical records	From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months