Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants
Recruiting
N/A
Interventional Study
Premature Lungs
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 0 Days – 30 Days
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Hospital Universitario 12 de Octubre · Other
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About This Trial
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 alte…
Trial Locations
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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:…
Contacts