We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fitting of Commonly Available Face Masks for Late Preterm and Term Infants (CAFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369028
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:

Around ten percent of newborn infants require positive pressure ventilation (PPV) in the delivery room. This is most commonly delivered using a round or anatomically shaped face mask attached to a T-piece device, self-inflating bag or flow-inflating bag. Face mask ventilation is a challenging technique and difficult to ensure that an appropriate tidal volume is delivered because large and variable leaks occur between the mask and face.

It is recommended by International Guidelines to start with mask ventilation by placing a fitting face mask on the babies face.

A fitting face mask covers the mouth and nose. A non-fitting overlaps the eyes and the chin, which causes a airleak. Studies report variable leak, sometimes more than 50% of inspiratory volume, during PPV in preterm infants in the delivery room. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation.

A study performed in preterm infants showed that most masks available are too big for the majority of those infants.

The investigators hypothesis is that the commonly available face masks for term infants are similarly too big for some term and late preterm infants (≥ 34 weeks gestation).


Condition or disease Intervention/treatment
Face Newborn Preterm Infant Other: 2D and 3D image of infants´ faces

Detailed Description:

The investigators would like to measure the dimensions of the faces of late preterm and term infants (≥ 34 SSW) within the first 72 hours of life and compare this data with the size of the most recommended available face masks:

VBM Germany:

external diameter smaller mask: 50 mm, external diameter bigger mask: 70 m

Laerdal:

external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm

Fisher&Paykel:

external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm

Therefore the investigators want to collect the following information from the participants:

Picture of the participant´s face (2D and 3D-Image) birth weight, head circumference, mode of delivery, gestational age, singletons/ twins/ triplets, date of birth

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort Intervention/treatment
2d and 3D image
A 2D and 3D image of the participants' face will be taken. It will at least last 2-3 sec.
Other: 2D and 3D image of infants´ faces
2D and 3D image of infants´ faces




Primary Outcome Measures :
  1. Mouth: Find out the best fitting facemask [ Time Frame: 1 year ]
    Measure distance in millimeters with ImageJ and 3DMaxSoftware from the nasofrontal groove to the mental protuberance and determine if the commonly available face masks fit this study population.

  2. Lips: Find out the best fitting facemask [ Time Frame: 1 year ]
    Measure the lateral points located at each labial commissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.

  3. Eyes: Find out the best fitting facemask [ Time Frame: 1 year ]
    Measure the points at the inner commissure of the eye fissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.

  4. Chin: Find out the best fitting facemask [ Time Frame: 1 year ]
    Measure length of the chin in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.


Secondary Outcome Measures :
  1. Gestational age [ Time Frame: 1 year ]
    Correlation between gestational age and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.

  2. Birth weight [ Time Frame: 1 year ]
    Correlation between birthweight and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.

  3. headcircumference [ Time Frame: 1 year ]
    Correlation between headcircumference and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.

  4. gender: male/female [ Time Frame: 1 year ]
    Correlation between gender (male/female) and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.

  5. way of delivery: spontaneous/cesarean [ Time Frame: 1 year ]
    Correlation between way of delivery and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware..


Biospecimen Retention:   Samples Without DNA
two-dimensional and three-dimensional images retained, with no potential for DNA extraction from any retained samples. Not working with any part of the body of the investigators´ participants.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Late preterm and term infants, gestational week ≥ 34 +0
  • 10 to 15 patients in every gestational-week
  • born at the University Hospital of Tuebingen
  • signed declaration of consent from the parents
  • ≤ 72 hours
Criteria

Inclusion Criteria:

  • Late preterm and term infants, gestational week ≥ 34 +0
  • born at the University Hospital of Tuebingen
  • signed declaration of consent from the parents
  • ≤ 72 hours

Exclusion Criteria:

  • congenital facial anomalies
  • any respirators or other medical device that covers the face
  • missing declaration of consent from the parents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369028


Locations
Layout table for location information
Germany
University clinic tuebingen
Tuebingen, Germany, 72072
Sponsors and Collaborators
University Hospital Tuebingen
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03369028    
Other Study ID Numbers: CAFF
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications