Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants (M3DPREMAT)

April 16, 2024 updated by: María Teresa Moral Pumarega, Hospital Universitario 12 de Octubre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D Mask (3DM)
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
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.
Active Comparator: Traditional Mask (TM)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in which preterm maintain SatO2 below 85%.
Time Frame: 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).
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in which preterm maintain bradycardias.
Time Frame: 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).
7 days
Time in which preterm maintain SatO2 below 75%.
Time Frame: 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).
7 days
Number of times requiring cardiopulmonary resuscitation
Time Frame: 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).
7 days
Appearance of cutaneous lesions in nasal region or mucosa
Time Frame: 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).
7 days
Pain assessment with scoring scale.
Time Frame: 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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario 12 de Octubre

Collaborators

ISCIII

Investigators

  • Principal Investigator: María Teresa Moral Pumarega, Hospital Universitario 12 de Octubre
  • Study Chair: Antonio Martín González, Mechanical Engineering, Hospital Universitario 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M3DPREMAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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