Status:

COMPLETED

Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Lead Sponsor:

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Conditions:

Newborn

Pressure Injury

Eligibility:

All Genders

Up to 6 years

Phase:

NA

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 Int...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • Pre-existing nasal lesion

Key Trial Info

Start Date :

December 2 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 16 2022

Estimated Enrollment :

280 Patients enrolled

Trial Details

Trial ID

NCT04293601

Start Date

December 2 2019

End Date

May 16 2022

Last Update

May 23 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122