CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
2D and 3D image of infants´ facesother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03369028
NCT03369028N/ACompleted

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

University Hospital Tuebingen·observational·Posted Dec 11, 2017·Updated May 30, 2019

In Brief

An observational study evaluating 2D and 3D image of infants´ faces for Face and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 11, 2017
Enrollment StartApr 10, 2018
Primary CompletionJan 30, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.6 years ago

Interventions

2D and 3D image of infants´ facesother

2D and 3D image of infants´ faces