Assessing Better Bottles for Babies

Launched by DUKE UNIVERSITY · Apr 4, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Assessing Better Bottles for Babies" is designed to explore how different types of baby bottles can affect weight gain in infants. Specifically, researchers want to see if the size of the bottle and whether the bottle is clear or opaque (not see-through) make a difference in how much weight babies gain during their early months. This study is open to babies aged 3 days to 1 month who are healthy and have a birth weight above a certain level. Caregivers must be at least 18 years old and plan to take their baby to a local clinic for regular check-ups. They also need to speak either English or Spanish.

If you decide to participate, you will use bottles that are assigned to you during the study, and you will stop using your current bottles for the duration of the trial. The goal is to find out which bottle design helps babies gain a healthy amount of weight. This research is important because understanding how feeding methods affect weight gain can help prevent issues like childhood obesity. If you're interested in learning more or think you might qualify, the study is currently recruiting participants!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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