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Completed

NCT Number: NCT04293601

Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

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.

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Key information

Conditions

Newborn Microcephaly, Primary Autosomal Recessive, 6 Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: prospective 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

Other names: retrospective group

Primary outcomes

  1. Number of Pressure nasal injuries

    Time frame: Through study completion, an average of 27 months

    Evaluation of the number of pressure nasal injuries

Secondary outcomes

  1. Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence

    Time frame: Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months

    Gestational Age (weeks) and postmenstrual age (weeks) will be collected from electronical medical records

  2. Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury

    Time frame: Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months

    Newborns' weight (grams) will be collected from electronical medical records

  3. Duration NCPAP treatment

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

    Duration NCPAP treatment (days) will be collected from electronical medical records

  4. Duration of NICU stay

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

    Duration of stay in NICU (days) will be collected from electronical medical records

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 3, 2020
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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