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

Launched by HOSPITAL UNIVERSITARIO 12 DE OCTUBRE · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of nasal mask made using 3D printing technology for premature infants who need help with breathing. Specifically, it compares this customized mask to a traditional mask to see which one helps maintain healthy oxygen levels better. The trial includes premature infants who weigh less than 1500 grams and are less than 30 days old, and who need non-invasive ventilation (NIV) support. Eligible infants must not have been on NIV for more than three days before joining the study.

During the trial, each baby will use both types of masks in a rotating schedule over a maximum of seven days. Researchers will monitor how long each infant maintains a safe oxygen level while using the different masks, and they will also check for any side effects like skin irritation or discomfort. Parents will be asked about their experience and satisfaction with the masks as well. This study aims to find the best breathing support option for these vulnerable infants, helping improve their care and comfort.

Gender

ALL

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