Evaluation of the effectiveness of One-size on-demand flow rate silicone nipple Versus Ordinary silicone nipple sizes in Infants: An Open-Label Randomized Controlled Trial Silicone nipple, Infants, One size on-demand flow rate silicone Nipple, Ordinary silicone nipple sizes
Conditions
Interventions
Participants will be randomized into two groups using sealed envelopes
Group 1 Infants receive the One Size on Demand Flow Rate Silicone Nipple
Baseline data on feeding bottle or nipple use and deliv
Experimental Device,Experimental Device
One size on demand flow rate silicone nipple ,Ordinary silicone nipple sizes
Sponsors
Natur Corporation Ltd.
Eligibility
Sex/Gender
All
Age
1 Days to 6 Months
Inclusion criteria
Inclusion criteria: 1. Term infants with gestational age of 37 weeks or more 2. Age 0 to 6 months 3. Birth weight 2500 grams or more 4. Healthy with no underlying diseases 5. Caregivers plan to bottle feed or unable to breastfeed directly 6. Informed consent obtained from caregivers
Exclusion criteria
Exclusion criteria: 1. Infants with congenital anomalies 2. Infants with sucking or swallowing disorders 3. Caregivers who do not consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feeding duration milk intake infant comfort during feeding caregiver satisfaction 6 months t test or Mann Whitney U test for continuous variables and Chi square or Fisher exact test for categorical data | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and need to change nipple size 6 months t test or Mann Whitney U test for continuous variables and Chi square or Fisher exact test for categorical data | — |
Countries
Thailand
Contacts
Public ContactChompoonoot Boonsopa
Naresuan university
Outcome results
None listed