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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.
Previous studies highlighted that nasal trauma, due to NCPAP support, is caused by the following risk factors:
However, previous studies results are mixed regarding factors affecting nasal injuries in neonates supported with NCPAP.
Interventions indicated as protective are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Standard care | Other | Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interventional nursing care | Other | The infants enrolled will receive different intervention according to a defined risk factor level: "Low":
Interventions:
"Medium":
Interventions:
"High":
Interventions:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pressure nasal injuries | Evaluation of the number of pressure nasal injuries | Through study completion, an average of 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisa Lagostina, RN | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27666491 | Background | 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. | |
| 28970314 | 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. |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| C564247 | Microcephaly, Primary Autosomal Recessive, 6 |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Newborns' interventional group are compared with infants born in 2018 who have received standard care interventions according to local protocol.
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| Standard nursing care | Other |
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|
|
| 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 |
| 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 |
| 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 |
| 23173614 | 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. |
| 28914355 | 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. |
| 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. |
| 41846515 | Derived | Lagostina E, Ferrario S, Zorz A, Sorrentino G, Fassino B, Colnaghi M, Mosca F, Fumagalli M, Plevani L. Prevention of Pressure Injuries During Nasal Continuous Positive Airway Pressure in Newborns: A Non-pharmacological Intervention Trial. Nurs Crit Care. 2026 May;31(3):e70444. doi: 10.1111/nicc.70444. |