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

NCT06224816 | Recruiting

• 1 other identifier: M3DPREMAT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Lungs

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)

Outcome Measures

Primary Outcomes (1)

• 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).

  7 days

Secondary Outcomes (5)

• Time in which preterm maintain bradycardias.

  7 days

• Time in which preterm maintain SatO2 below 75%.

  7 days

• Number of times requiring cardiopulmonary resuscitation

  7 days

• Appearance of cutaneous lesions in nasal region or mucosa

  7 days

• Pain assessment with scoring scale.

  7 days

Study Arms (2)

3D Mask (3DM)

EXPERIMENTAL

Custom 3D mask (3DM) application in neonate during 4 hours. 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.

Device: Custom 3D mask (3DM) application in neonate; Device: Traditional mask (TM) application in neonate

Traditional Mask (TM)

ACTIVE COMPARATOR

Traditional Mask (TM) application in neonate during 4 hours. 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.

Device: Custom 3D mask (3DM) application in neonate; Device: Traditional mask (TM) application in neonate

Interventions

Custom 3D mask (3DM) application in neonate DEVICE

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

3D Mask (3DM); Traditional Mask (TM)

Traditional mask (TM) application in neonate DEVICE

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

3D Mask (3DM); Traditional Mask (TM)

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Failure to meet entry criteria
• Cyanotic congenital heart disease diagnosis
• Presence of serious malformations
• Presence of airway malformations

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• ISCIII: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Related Publications (17)

• 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 BACKGROUND

• 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.

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• 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.

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• 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 BACKGROUND

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  PMID: 29219007 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Stenson BJ. Oxygen targets for preterm infants. Neonatology. 2013;103(4):341-5. doi: 10.1159/000349936. Epub 2013 May 31.

  PMID: 23736013 BACKGROUND

• Bose CL, Dammann CE, Laughon MM. Bronchopulmonary dysplasia and inflammatory biomarkers in the premature neonate. Arch Dis Child Fetal Neonatal Ed. 2008 Nov;93(6):F455-61. doi: 10.1136/adc.2007.121327. Epub 2008 Aug 1.

  PMID: 18676410 BACKGROUND

• Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.

  PMID: 30974433 BACKGROUND

• Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3-23. doi: 10.1159/000528914. Epub 2023 Feb 15.

  PMID: 36863329 BACKGROUND

• Roh S, Parekh DP, Bharti B, Stoyanov SD, Velev OD. 3D Printing by Multiphase Silicone/Water Capillary Inks. Adv Mater. 2017 Aug;29(30). doi: 10.1002/adma.201701554. Epub 2017 Jun 7.

  PMID: 28590510 BACKGROUND

• Hinton TJ, Hudson A, Pusch K, Lee A, Feinberg AW. 3D Printing PDMS Elastomer in a Hydrophilic Support Bath via Freeform Reversible Embedding. ACS Biomater Sci Eng. 2016 Oct 10;2(10):1781-1786. doi: 10.1021/acsbiomaterials.6b00170. Epub 2016 May 4.

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• Bhattacharjee N, Parra-Cabrera C, Kim YT, Kuo AP, Folch A. Desktop-Stereolithography 3D-Printing of a Poly(dimethylsiloxane)-Based Material with Sylgard-184 Properties. Adv Mater. 2018 May;30(22):e1800001. doi: 10.1002/adma.201800001. Epub 2018 Apr 14.

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• Clarke A, Yeomans E, Elsayed K, Medhurst A, Berger P, Skuza E, Tan K. A randomised crossover trial of clinical algorithm for oxygen saturation targeting in preterm infants with frequent desaturation episodes. Neonatology. 2015;107(2):130-6. doi: 10.1159/000368295. Epub 2014 Dec 12.

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• Duong K, Glover J, Perry AC, Olmstead D, Ungrin M, Colarusso P, MacLean JE, Martin AR. Feasibility of three-dimensional facial imaging and printing for producing customised nasal masks for continuous positive airway pressure. ERJ Open Res. 2021 Feb 1;7(1):00632-2020. doi: 10.1183/23120541.00632-2020. eCollection 2021 Jan.

  PMID: 33569497 BACKGROUND

• Kamath AA, Kamath MJ, Ekici S, Stans AS, Colby CE, Matsumoto JM, Wylam ME. Workflow to develop 3D designed personalized neonatal CPAP masks using iPhone structured light facial scanning. 3D Print Med. 2022 Aug 1;8(1):23. doi: 10.1186/s41205-022-00155-7.

  PMID: 35913689 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• María Teresa Moral Pumarega

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

• Antonio Martín González, Mechanical Engineering

  Hospital Universitario 12 de Octubre

  STUDY CHAIR

Central Study Contacts

María Teresa Moral Pumarega

CONTACT

649921733; mmoralp@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics at the Complutense University of Madrid (UCM)

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 25, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

ES (1)