RecruitingNot ApplicableNCT06357299
Assessing Better Bottles for Babies
Assessing Better Bottles for Babies (AB3)
Sponsor
Duke University
Enrollment
76 participants
Start Date
May 28, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain.
Eligibility
Min Age: 3 DaysMax Age: 1 Month
Inclusion Criteria7
- Child is 3 days old to 1 month old
- Greater than 37 weeks gestational age at birth
- Birth weight greater than 3% for sex-specific WHO growth standard
- Caregiver must plan to use local clinic as infant's primary medical home for first 6 months of life
- Caregiver must speak English or Spanish as primary preferred language
- Caregiver age 18 years or older
- Caregiver must agree to use intervention bottles assigned during randomization and agree to stop using their existing bottles during the study period
Exclusion Criteria4
- Multiple gestation
- Significant congenital anomaly or acquired or inherited condition directly affecting feeding, physiology, metabolism, or growth
- Feeding with soy-based, hydrolyzed, lactose-reduced, or elemental formula
- Weight loss greater than 95% for population reference in the first two weeks of life
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Interventions
BEHAVIORALSmall Bottle Size
Small sized bottle
BEHAVIORALStandard Bottle Size
Standard sized bottle
BEHAVIORALClear Bottle
Clear bottle
BEHAVIORALOpaque Bottle
Opaque bottle
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06357299
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