NCT06224816View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 16, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Premature Lungs
Interventions
DEVICE

Custom 3D mask (3DM) application in neonate

Premature infants with a birth weight less than 1500 g r first received 3D mask during 4 hour, then crossed over to traditional mask.

DEVICE

Traditional mask (TM) application in neonate

Premature infants with a birth weight less than 1500 g r first received traditional mask during 4 hours, then crossed over to 3D mask.

Trial Locations (1)

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

All Listed Sponsors
collaborator

ISCIII

UNKNOWN

lead

Hospital Universitario 12 de Octubre

OTHER