An observational study in Face, Newborn and Preterm Infant, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged Up to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by University Hospital Tuebingen · Observational
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).
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
220 studies on the registry are indexed under Facies; 37 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 51 observational studies indexed under Facies.
Browse Facies studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
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Exclusion Criteria:
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
Mouth: Find out the best fitting facemask
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.
Time frame: 1 year
Lips: Find out the best fitting facemask
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.
Time frame: 1 year
Eyes: Find out the best fitting facemask
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.
Time frame: 1 year
Chin: Find out the best fitting facemask
Measure length of the chin in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
Time frame: 1 year
Gestational age
Correlation between gestational age and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
Time frame: 1 year
Birth weight
Correlation between birthweight and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
Time frame: 1 year
headcircumference
Correlation between headcircumference and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
Time frame: 1 year
gender: male/female
Correlation between gender (male/female) and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
Time frame: 1 year
way of delivery: spontaneous/cesarean
Correlation between way of delivery and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware..
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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