Healthy infant and adult
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy infant (1 to 2 months old or 4 to 5 months old) who has undergone a 1 or 4 month medical check-up and his/her guardian (parents, grandparents or cohabiter of the infant excluding minor) 2. Subject who voluntarily agreed in writing with sufficient understanding after the guardian, who is the proxy for his/her infant and the subject of the study, received sufficient explanation about the purpose and contents of this study 3. Both the infant and his/her guardian are inexperienced in cup-feeding
Exclusion criteria
Exclusion criteria: 1. Infant who has allergy to cow's milk 2. Infant who has no experience in suckling infant formula 3. Infant or his/her guardian who has participated in other clinical trial within three months 4. Infant with notable serious illness and morphological abnormalities 5. Infant or his/her guardian who is judged ineligible by investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infant's formula intake per one cup-feeding by guardian who has no experience in cup feeding | — |
Secondary
| Measure | Time frame |
|---|---|
| - Spilled amount, feeding time and state of infant and guardian per one cup-feeding - Infant's formula intake per one cup-feeding by guardian who has experience in cup-feeding - Success ratio of cup-feeding - Difference between each evaluation item between the initial test and the additional test | — |
Countries
Japan
Contacts
Showa University, School of Dentistry Department of Hygiene and Oral Health