The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. Anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.
Parents / legally acceptable representatives of eligible infants will be invited to volunteer.
Study Type
OBSERVATIONAL
Enrollment
460
Infants who are exclusively fed the new study formula at time of enrollment
Infants who are exclusively fed human milk at time of enrollment
Infants who are exclusively fed human milk and the new study formula at time of enrollment
The 306th Hospital of PLA
Chaoyang District, Beijing Municipality, China
Beijing Haidian Maternal&Child Health Hospital
Haidian District, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhu Jiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China
...and 14 more locations
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Time frame: Baseline
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Time frame: day 15
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Time frame: day 30
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Time frame: day 45
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Time frame: Baseline
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Time frame: day 18
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Time frame: day 48
Infant and parent health-related quality of life (assessed using validated parent questionnaires)
Time frame: Baseline
Infant and parent health-related quality of life (assessed using validated parent questionnaires)
Time frame: day 48
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