Clinical trial NCT06224816: Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Lungs
Keywords: Neonatology
Nasal mask
3D printing
Additive manufacturing
Newborn
Premature
Prematurity
Neonate
Non-Invasive Ventilation (NIV)
Oxygen saturation
SolidWorks
3D scanner
Customized device
Continuous positive airway pressure (CPAP)
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: ISCIII
First posted: 2024-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in which preterm maintain SatO2 below 85%.
timeFrame: 7 days
Secondary outcomes:
measure: Time in which preterm maintain bradycardias.
timeFrame: 7 days
measure: Time in which preterm maintain SatO2 below 75%.
timeFrame: 7 days
measure: Number of times requiring cardiopulmonary resuscitation
timeFrame: 7 days
measure: Appearance of cutaneous lesions in nasal region or mucosa
timeFrame: 7 days
measure: Pain assessment with scoring scale.
timeFrame: 7 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: María Teresa Moral Pumarega
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre
name: Antonio Martín González, Mechanical Engineering
role: STUDY_CHAIR
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