NCT03369028: CAFF

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

Completed Last updated 30 May 2019

What this trial tests

trial testing 2D and 3D image of infants´ faces in Face in 100 participants. Completed in 30 January 2019.

Timeline

10 April 2018

Primary endpoint
30 January 2019

30 January 2019

Quick facts

Lead sponsor	University Hospital Tuebingen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	10 April 2018
Primary completion	30 January 2019
Estimated completion	30 January 2019
Sites	1 location across Germany

Drugs / interventions tested

• 2D and 3D image of infants´ faces

Conditions studied

• Face — all drugs for Face →
• Newborn — all drugs for Newborn →
• Preterm Infant — all drugs for Preterm Infant →

Sponsor

University Hospital Tuebingen

Who can join

Under 72 Hours, any sex, with Face or Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Do commonly available round facemasks fit near-term and term infants?
   Haase B, Badinska AM, Koos B, Poets CF, et al · · 2020 · cited 4× · PMID 31542729 · DOI 10.1136/archdischild-2019-317531
2. Comparison of nostril sizes of newborn infants with outer diameter of endotracheal tubes.
   Haase B, Badinska AM, Maiwald CA, Poets CF, et al · · 2021 · cited 1× · PMID 34556062 · DOI 10.1186/s12887-021-02889-5