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

Official title

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

Overview

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

• 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.

Primary outcome measures

• Time in which preterm maintain SatO2 below 85%. [Time frame: 7 days]

Secondary outcome measures (5)

• Time in which preterm maintain bradycardias. [Time frame: 7 days]
• Time in which preterm maintain SatO2 below 75%. [Time frame: 7 days]
• Number of times requiring cardiopulmonary resuscitation [Time frame: 7 days]
• Appearance of cutaneous lesions in nasal region or mucosa [Time frame: 7 days]
• Pain assessment with scoring scale. [Time frame: 7 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universitario 12 de Octubre — Madrid

Publications

• Al-Ramahi J, Luo H, Fang R, Chou A, Jiang J, Kille T. Development of an Innovative 3D Printed Rigid Bronchoscopy Training Model. Ann Otol Rhinol Laryngol. 2016 Dec;125(12):965-969. doi: 10.1177/0003489416667742. Epub 2016 Sep 7. PMID 27605436
• Zheng J, He H, Kuang W, Yuan W. Presurgical nasoalveolar molding with 3D printing for a patient with unilateral cleft lip, alveolus, and palate. Am J Orthod Dentofacial Orthop. 2019 Sep;156(3):412-419. doi: 10.1016/j.ajodo.2018.04.031. PMID 31474271
• Hadeed K, Dulac Y, Acar P. Three-dimensional printing of a complex CHD to plan surgical repair. Cardiol Young. 2016 Oct;26(7):1432-4. doi: 10.1017/S1047951116000755. Epub 2016 Jun 20. PMID 27321706
• Xu JJ, Luo YJ, Wang JH, Xu WZ, Shi Z, Fu JZ, Shu Q. Patient-specific three-dimensional printed heart models benefit preoperative planning for complex congenital heart disease. World J Pediatr. 2019 Jun;15(3):246-254. doi: 10.1007/s12519-019-00228-4. Epub 2019 Feb 22. PMID 30796731
• Zhao H, Lin G, Seong YH, Shi J, Xu J, Huang W. Anthropometric research of congenital auricular deformities for newborns. J Matern Fetal Neonatal Med. 2019 Apr;32(7):1176-1183. doi: 10.1080/14767058.2017.1402877. Epub 2017 Dec 8. PMID 29219007
• Minocchieri S, Burren JM, Bachmann MA, Stern G, Wildhaber J, Buob S, Schindel R, Kraemer R, Frey UP, Nelle M. Development of the premature infant nose throat-model (PrINT-Model): an upper airway replica of a premature neonate for the study of aerosol delivery. Pediatr Res. 2008 Aug;64(2):141-6. doi: 10.1203/PDR.0b013e318175dcfa. PMID 18391845
• Saugstad OD, Aune D. Optimal oxygenation of extremely low birth weight infants: a meta-analysis and systematic review of the oxygen saturation target studies. Neonatology. 2014;105(1):55-63. doi: 10.1159/000356561. Epub 2013 Nov 15. PMID 24247112
• Stenson BJ. Oxygen targets for preterm infants. Neonatology. 2013;103(4):341-5. doi: 10.1159/000349936. Epub 2013 May 31. PMID 23736013

Identifiers

NCT: NCT06224816 · M3DPREMAT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗