Clinical trial NCT04293601: Pressure Injuries' Prevention in Newborn Infants Admitted to NICU
Official title: Pressure Injuries' Prevention in Newborn Infants Admitted to NICU Receiving Noninvasive Respiratory Support With Nasal Continuous Positive Airway Pressure (NCPAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn
Pressure Injury
Keywords: Cpap
NICU
nasal trauma
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 280
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Newborns' interventional group are compared with infants born in 2018 who have received standard care interventions according to local protocol.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of Pressure nasal injuries
timeFrame: Through study completion, an average of 27 months
Secondary outcomes:
measure: Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence
timeFrame: Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months
measure: Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury
timeFrame: Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months
measure: Duration NCPAP treatment
timeFrame: From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months
measure: Duration of NICU stay
timeFrame: From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Elisa Lagostina, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. No abstract available.
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.
citation: 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.