Breastfeeding women Nipple confusion,
Conditions
Interventions
After being approved by the Siriraj Institutional Review Board (SiRB),
the eligible women at postpartum ward,
Division of Breastfeeding,
Department of Obstetrics and Gynaecology,
Sirjiraj Hospital,
Mahidol University will be invited to participate in the study. The fact of the research including the process and its benefit will be informed to all participants.
Patients who decide to take
Division of Child Development,
Department of Pediatric. Both mother and infant who are qualified and have given their informed consents will be taken patient’s history and demographic data. The pediatrician will perform general
measure infant weight and length and record the information as the baseline data. All participants will be randomly allocated into either group A or group B of treatment according to the letter place
the women will be provided a bag containing 4 sets of 160-
ml feeding bottles plus size SS nipples (Pigeon Peristaltic PLUSTM),
1 set of manual breast pump and milk storage bags for 12 weeks.
The trademark or logo of each feeding bottle and nipple is completely removed before the distribution. All women will be informed how
bottle feeding and nipples properly. A diary book for recording infant feeding type,
infant behavior and nipple confusion event will be given to every participant. The mother has to collect the data twice a week for 4 weeks (total
Experimental Device,Active Comparator Device
Bottle and Nipple Design Type A,Bottle and Nipple Design Type B
Sponsors
Obstetric and Gynaecology Department, Faculty of Medicine, SIriraj Hospital, Mahidol University
Pediatrics Department,
Faculty of Medicine,
SIriraj Hospital,
Mahidol University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ์Nipple confusion prevalence 16 weeks after enrollment Observation | — |
Secondary
| Measure | Time frame |
|---|---|
| Infant growth and feeding type 16 weeks after enrollment Observation | — |
Countries
Thailand
Contacts
Public ContactPharuhas Chanprapaph
Obstetric and Gynaecology Department, Faculty of Medicine, SIriraj Hospital, Mahidol University
Outcome results
None listed