Evaluation of customized 3D printed nasal masks for 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
Run by Hospital Universitario 12 de Octubre · NCT06224816 · Data updated 2026-11-12
This study tests if specially made 3D printed nasal masks can help premature babies breathe better than regular masks during their treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 30 Days |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid) |
| Status | Recruiting |
| Started | April 16, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | April 18, 2024 |
| Trial ID | NCT06224816 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are premature infants under 30 days old, weighing less than 1500 grams, and requiring non-invasive ventilation.
✕Probably not a fit
Patients with cyanotic congenital heart disease, serious malformations, or airway malformations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of customized 3D printed nasal masks compared to traditional masks for non-invasive ventilation in premature infants weighing less than 1500 grams. The study involves randomizing infants to receive each type of mask alternately every four hours over a maximum period of seven days. Key outcomes include the time spent with oxygen saturation below 85%, as well as secondary objectives related to respiratory stability, skin integrity, and parental satisfaction. The goal is to enhance respiratory support and reduce complications associated with non-invasive ventilation.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory outcomes and reduce complications in premature infants requiring non-invasive ventilation.
How similar studies have gone: While the use of 3D printing in medical applications is gaining traction, this specific approach in neonatology is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospital Universitario 12 de Octubre
Madrid, Spain Recruiting
Study contacts
- Principal investigator: María Teresa Moral Pumarega — Hospital Universitario 12 de Octubre
- Study coordinator: María Teresa Moral Pumarega
- Email: mmoralp@salud.madrid.org
- Phone: 649921733
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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We will try the FDA-approved DandleLion NeoBellyBand on premature infants needing CPAP to see if it thickens their rectus abdominis muscle and helps them reach full oral feedings sooner.
-
Comparing breathing support methods for preterm infants
This study is testing which breathing support method, CPAP or NIPPV, works better for very low birth weight preterm infants by comparing how their diaphragm functions while using each method.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.