Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV). Premature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days. To compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm \< 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and/or sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 month
Healthy Volunteers: f
View:

• Newborn prematurity

• Age: less than 30 days of life

• Required respiratory support with non-invasive ventilation (NIV)

• Premature infant has not been on NIV for more than 3 days before being included in the trial.

• Signature of the Informed Consent (IC)

Locations
Other Locations
Spain
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Contact Information
Primary
María Teresa Moral Pumarega
mmoralp@salud.madrid.org
649921733
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: 3D Mask (3DM)
Custom 3D mask (3DM) application in neonate during 4 hours. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.
Active_comparator: Traditional Mask (TM)
Traditional Mask (TM) application in neonate during 4 hours. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.
Related Therapeutic Areas
Sponsors
Collaborators: ISCIII
Leads: Hospital Universitario 12 de Octubre

This content was sourced from clinicaltrials.gov