Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants

What this Trial Is About

Researchers are evaluating customized nasal masks made by 3D printing for non-invasive ventilation (NIV) in premature infants weighing less than 1500 grams. The study aims to compare the time these infants maintain blood oxygen saturation (SatO2) below 85% using the 3D printed mask versus a traditional mask. Secondary goals include assessing apnea-related events like bradycardias, cardiorespiratory arrests, resuscitation needs, nasal skin injuries, pain control requirements, and parental satisfaction. Premature infants who need NIV will receive both the customized 3D printed mask and the traditional mask alternately every 4 hours, serving as their own control. The maximum study period is 7 days. This crossover design allows direct comparison of the two mask types within the same infant. The customized mask is tailored to each infant's nose anatomy to potentially improve ventilation and comfort. During the study, infants will be closely monitored for oxygen levels, heart rate events, skin condition on the nose, and pain using scoring scales. Researchers will also record any need for cardiopulmonary resuscitation. Parents' perceptions and satisfaction with the masks will be collected. The study is sponsored by Hospital Universitario 12 de Octubre and includes infants up to 30 days old who have been on NIV for less than 3 days before enrollment.

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