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

Preterm Infant Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Face
• Newborn
• Premature Birth
• Preterm Infant

• NCT number: NCT03369028
• Study type: Observational
• Source: University Hospital Tuebingen
• Status: Completed
• Start date: April 10, 2018
• Completion date: January 30, 2019