Develop a new device using for nasal emission tests in cleft lip and palate

JRCT ID: jRCTs062180020

Registered date:05/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cleft lip and palate, Cleft palate
• Date of first enrollment: 01/12/2017
• Target sample size: 67
• Study type: Interventional
• Intervention(s): We divided subjects into cleft lip and palate and healthy infants, each groups are conducted a nasal emission tests and recorded at 2, 4, 6, 8 months after research registration.

Outcome(s)

• Primary Outcome: difference between conventional method of nasal emission tests and a new device

Secondary Outcome

impression from using
relations between each groups and success rate of tests
reliability of results from

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: < 7age old
• Gender: Both

Include criteria

Cleft lip and palate patients:
1)2~6 years old, unlimited by gender
2)post operation of palatoplasty
3)having no-remarkable basal disease for research
healthy children:
1)2~6 years old and year matched with cleft lip and palate patients group
2)no cleft palate
3)having no-remarkable basal disease for research

Exclude criteria

Cleft lip and palate patients:
1)not agree with research
2)difficult of periodical follow-up
3)inadequate for research
healthy children:
1)not agree with research
2)inadequate for research

Related Information

• Primary Sponsor: Doi Rieko
• Secondary ID(s): UMIN000034835