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"ChildMask - protective mask for children / adolescents with improved wearing comfort and infection protection - in relation to Covid 19 and other infectious diseases - a follow-up"

"ChildMask - protective mask for children / adolescents with improved wearing comfort and infection protection - in relation to Covid 19 and other infectious diseases - a follow-up" - ChildMask

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034563
Enrollment
40
Registered
2024-06-27
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No ICD 10-coded disease, examination of healthy subjects

Interventions

Group 1: After randomization, healthy children aged 6-14 years receive a treadmill exercise at an individual speed adapted to them of max. 10km/h, after the general inclusion examination (blood pressu

Sponsors

Universitätsklinik für Kinder- und Jugendmedizin Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: healthy

Exclusion criteria

Exclusion criteria: chronical diseases

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Carbon dioxide partial pressure in mmHg measured in ABG before and after treadmill exercise Hypothesis I: According to current studies, the type of mask investigated does not result in significant carbon dioxide retention or a significant drop in oxygen saturation during exercise on the treadmill, and is therefore not medically inferior to exercise without a mask.

Secondary

MeasureTime frame
Secondary endpoint: Oxygen saturation in % measured with a pulse oximetry device during treadmill exercise. Wearing comfort of an FFP2 mask adapted to children using standardized questionnaires on mask wearing comfort and symptoms when wearing the mask at the beginning and at the end of the one-hour test. Hypothesis II: Increased wearing comfort improves the acceptance of wearing a mask in children and adolescents.

Countries

Germany

Contacts

Public ContactFolke; Brinkmann;

Universitätsklinik für Kinder- und Jugendmedizin Bochum;etna GmbH

studien-kinderklinik@klinikum-bochum.de;0234/509-2611;+49 69/40 351 – 300

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026