Clinical trial NCT03369028: Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
Official title: Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Face
Newborn
Preterm Infant
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 100
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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

Eligibility 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

Primary outcomes:
measure: Mouth: Find out the best fitting facemask
timeFrame: 1 year
measure: Lips: Find out the best fitting facemask
timeFrame: 1 year
measure: Eyes: Find out the best fitting facemask
timeFrame: 1 year
measure: Chin: Find out the best fitting facemask
timeFrame: 1 year
Secondary outcomes:
measure: Gestational age
timeFrame: 1 year
measure: Birth weight
timeFrame: 1 year
measure: headcircumference
timeFrame: 1 year
measure: gender: male/female
timeFrame: 1 year
measure: way of delivery: spontaneous/cesarean
timeFrame: 1 year
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University clinic tuebingen
Study officials:
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