Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants

Recruiting now · Not applicable

Conditions studied: Premature Lungs

In brief

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.

Key facts

Study ID

NCT06224816

Run by

Hospital Universitario 12 de Octubre

People needed

60

Starts

2024-04-16

Expected to finish

2026-12-01

Last updated by the study team

2024-04-18

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Failure to meet entry criteria
• Cyanotic congenital heart disease diagnosis
• Presence of serious malformations
• Presence of airway malformations

Where it is running

• Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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