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.
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.
Failure to meet entry criteria
Cyanotic congenital heart disease diagnosis
Presence of serious malformations
Presence of airway malformations
Crossover
Custom 3D mask (3DM) application in neonate
DevicePremature infants with a birth weight less than 1500 g r first received 3D mask during 4 hour, then crossed over to traditional mask.
Traditional mask (TM) application in neonate
DevicePremature infants with a birth weight less than 1500 g r first received traditional mask during 4 hours, then crossed over to 3D mask.
Time in which preterm maintain SatO2 below 85%.
To compare the time in which preterm maintain SatO2 below 85%.in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Time in which preterm maintain bradycardias.
To compare the time in which preterm maintain bradycardias - heart rate below 100 beats per minute - that occur in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Time in which preterm maintain SatO2 below 75%.
To compare the time in which preterm maintain SatO2 below 75%.in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Number of times requiring cardiopulmonary resuscitation
Compare the number of times requiring cardiorespiratory resuscitation with self-inflating bag in the context of apnea pause or severe desaturation in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Appearance of cutaneous lesions in nasal region or mucosa
To compare the appearance of cutaneous lesions in the nasal region or nasal mucosa as a consequence of the pressure exerted by any of the masks, indicating the location and degree of the wound in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
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Hospital Universitario 12 de Octubre
Lead sponsor
ISCIII
Collaborator
