NCT06224816 Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants
| NCT ID | NCT06224816 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario 12 de Octubre |
| Condition | Premature Lungs |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-04-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
María Teresa Moral Pumarega
PRINCIPAL INVESTIGATOR
Hospital Universitario 12 de Octubre
Frequently Asked Questions
Who can join the NCT06224816 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 30 Days, studying Premature Lungs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06224816 currently recruiting?
Yes, NCT06224816 is actively recruiting participants. Contact the research team at mmoralp@salud.madrid.org for enrollment information.
Where is the NCT06224816 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06224816 clinical trial?
NCT06224816 is sponsored by Hospital Universitario 12 de Octubre. The principal investigator is María Teresa Moral Pumarega at Hospital Universitario 12 de Octubre. The trial plans to enroll 60 participants.