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Completed

NCT Number: NCT03369028

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

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).

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Key information

Conditions

Face Disease Attributes Facies Female Urogenital Diseases and Pregnancy Complications Newborn Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Preterm Infant Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

University clinic tuebingen

Tübingen, 72072, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2D and 3D image of infants´ faces

Other

2D and 3D image of infants´ faces

Primary outcomes

  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 outcomes

  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..

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: CAFF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2017
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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