Evaluation the effect of teat and bottle design on infant behavior when direct-breastfeeding and bottle feeding switching is necessary: A randomized controlled trial
- Conditions
- Breastfeeding womenNipple confusion,bottle and nipple design,randomized controlled tiral
- Registration Number
- TCTR20160516001
- Lead Sponsor
- Obstetric and Gynaecology Department, Faculty of Medicine, SIriraj Hospital, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 100
1.Mother who delivered healthy, term, singleton infant with birth weight not less than 2.5 kg without congenital anomaly or medical disease. The infant must be 4-6 weeks old.
2.Mother with age between 18-45 years old
3.Mother with healthy physical condition with ability to communicate in Thai language
4.Mother with early successful breastfeeding with no prior nipple confusion condition
5.Mother with normal anatomy of nipples and breasts
6.Mother who needs to have mixed infant feeding between direct breast feeding (at least once a day) and bottle feeding due to return to work or school
7.Mother with adequate milk supply and the infant has normal growth during the first 4 weeks of age
8.Mother who intends to participate into this study and has given her informed consent
1.Infant who has central nervous anomaly and/or genetic disorder such as Down’s syndrome
2.Infant with swallowing problem and needs to be intubated with NG tube
3.Infant who regularly uses pacifiers during the first 4 weeks after birth.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ์Nipple confusion prevalence 16 weeks after enrollment Observation
- Secondary Outcome Measures
Name Time Method Infant growth and feeding type 16 weeks after enrollment Observation