MedTrace Logo

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

NCT03369028 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-05-30

No results posted yet for this study

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).

Conditions

  • Face
  • Newborn
  • Preterm Infant

Interventions

OTHER

2D and 3D image of infants´ faces

2D and 3D image of infants´ faces

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2019-01-30
Completion
2019-01-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369028 on ClinicalTrials.gov