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

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Fitting of Commonly Available Face Masks for Late Preterm and Term Infants

Conditions
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Face, Newborn, Preterm Infant

Intervention / Treatment
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* Other: 2D and 3D image of infants´ faces


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2d and 3D image<br>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<br>* 2D and 3D image of infants´ faces<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age | Correlation between gestational age and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware. | 1 year | 
| Birth weight | Correlation between birthweight and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware. | 1 year | 
| headcircumference | Correlation between headcircumference and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware. | 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. | 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.. | 1 year |