Premature Lungs
Conditions
Keywords
Neonatology, Nasal mask, 3D printing, Additive manufacturing, Newborn, Premature, Prematurity, Neonate, Non-Invasive Ventilation (NIV), Oxygen saturation, SolidWorks, 3D scanner, Customized device, Continuous positive airway pressure (CPAP)
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.
Detailed description
Improvement and optimization of non-invasive ventilation (NIV) in preterm and low birth weight infants is essential in order to reduce morbidity. By the use of 3D printing design (3DM), these infants would be provided with customized nasal masks, according to their particular anatomical features while on NIV. This would lead to a greater stabilization of the respiratory system, decreased apnea spells, oxygen desaturation and bradycardia, less need for intubation and less skin nose injury, all of which might improve neurodevelopmental outcomes.
Interventions
DEVICECustom 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.
DEVICETraditional 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.
Sponsors
ISCIII
Hospital Universitario 12 de Octubre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 30 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in which preterm maintain SatO2 below 85%. | 7 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in which preterm maintain bradycardias. | 7 days | 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%. | 7 days | 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 | 7 days | 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 | 7 days | 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). |
| Pain assessment with scoring scale. | 7 days | To compare the degrees of pain, measured in the neonatal pain scale PIPP-R (Premature Infant Pain Profile-Revised), obtained every 12 hours in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM). Regarding the PIPP-R scale, the minimum score is 1 and the maximum is 21. Scores between 1-6 correspond to mild pain, 7-11 moderate pain, and 12-21 severe pain. |
Countries
Spain
Contacts
Primary ContactMaría Teresa Moral Pumarega
Outcome results
None listed