A clinical trial to assess the confidence, usability, preference and satisfaction on use of Baby Mask with valve from parents of children who are healthy or who have mild Asthma.

An open, prospective, single centre study to assess the confidence, usability, preference and satisfaction on use of Baby Mask with valve from parents of children who are healthy or who have mild Asthma.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000958

Enrollment

Registered

2009-12-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: J452- Mild intermittent asthma

Interventions

Intervention1: Baby Mask with valve: Study Treatment: Placebo, Duration of Treatment: Approximately 4 days (Two visits one day apart from each other with plus one day window period for visit-2) Contro

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children whose parents are willing to sign written informed consent 2. Children between 1 to 5 years of age 3.Children who are healthy or who have mild asthma

Exclusion criteria

Exclusion criteria: 1. Children already using Baby Mask with valve (Cipla Ltd), prior to start of the study.

Design outcomes

Primary

Measure	Time frame
Average time taken for 3 consecutive correct attempts during the first and second visit.Timepoint: Between Visit-1 and Visit-2	—

Secondary

Measure	Time frame
Confidence assessmentTimepoint: Between Visit-1 and Visit-2;Preference assessmentTimepoint: Between Visit-1 and Visit-2;Satisfaction assessmentTimepoint: Between Visit-1 and Visit-2;Type and number of errors during first and second visit.Timepoint: Between Visit-1 and Visit-2;Usability assessmentTimepoint: Between Visit-1 and Visit-2	—

Countries

India

Contacts

Public ContactDr Keya Lahiri

Cipla Ltd.

jgogtay@cipla.com022-23025412

Outcome results

None listed

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