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

University Hospital Tuebingen

Status: Completed

Conditions: Face; Preterm Infant; Newborn

Treatments: Other: 2D and 3D image of infants´ faces

Study type: Observational

Funder types: Other

Identifiers

NCT03369028

CAFF

Details and patient eligibility

About

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).

Full 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

Enrollment: 100 patients

Sex: All

Ages: Under 72 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

2d and 3D image

Description:

A 2D and 3D image of the participants' face will be taken. It will at least last 2-3 sec.

Treatment:

Other: 2D and 3D image of infants´ faces