Evaluation of customized 3D printed nasal masks for premature infants
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
This study tests if specially made 3D printed nasal masks can help premature babies breathe better than regular masks during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 0 Days to 30 Days |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06224816 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are premature infants under 30 days old, weighing less than 1500 grams, and requiring non-invasive ventilation.
Not a fit: Patients with cyanotic congenital heart disease, serious malformations, or airway malformations may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.