Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants (M3DPREMAT)

Madrid Health Service

Status: Enrolling

Conditions: Premature Lungs

Treatments: Device: Traditional mask (TM) application in neonate; Device: Custom 3D mask (3DM) application in neonate

Study type: Interventional

Funder types: Other

Identifiers

NCT06224816

M3DPREMAT

Details and patient eligibility

About

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.

Full description

Improvement and optimization of non-invasive ventilation (NIV) in preterm and low birth weight infants is essential in order to reduce morbidity. By the use of 3D printing design (3DM), these infants would be provided with customized nasal masks, according to their particular anatomical features while on NIV. This would lead to a greater stabilization of the respiratory system, decreased apnea spells, oxygen desaturation and bradycardia, less need for intubation and less skin nose injury, all of which might improve neurodevelopmental outcomes.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

3D Mask (3DM)

Experimental group

Description:

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.

Treatment:

Device: Traditional mask (TM) application in neonate

Device: Custom 3D mask (3DM) application in neonate

Traditional Mask (TM)

Active Comparator group

Description:

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.

Treatment:

Device: Traditional mask (TM) application in neonate

Device: Custom 3D mask (3DM) application in neonate