Actively Recruiting
Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants
Led by Hospital Universitario 12 de Octubre · Updated on 2024-04-18
60
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitario 12 de Octubre
Lead Sponsor
I
ISCIII
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborn prematurity
- Age less than 30 days of life
- Requires respiratory support with non-invasive ventilation (NIV)
- Has been on NIV for no more than 3 days before joining the trial
- Signed informed consent obtained
You will not qualify if you...
- Does not meet the entry criteria
- Diagnosed with cyanotic congenital heart disease
- Has serious malformations
- Has airway malformations
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
Research Team
M
María Teresa Moral Pumarega
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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