Tiny Tummies - A Milk Study

Microbial DNA extracted from toddler stool samples will undergo shotgun metagenomic sequencing to identify the unique species present in the gut microbial community and evaluate the richness and abundance of microbes present in the stool.

Toddler length will be assessed with a pediatric length board and reported in centimeters.

Infant weight will be assessed with a calibrated scale and reported in grams.

A questionnaire completed by the parent/caregiver that is normed for ages from birth through 90 years. The tool assesses adaptive behaviors (things people do to function in everyday life) in three domains: communication, daily living skills, and socialization.

A widely used checklist completed by parents to assess children's early communication skills such as comprehension and use of gestures and words.

Study staff will administer a structured 15-minute play session with the infant to objectively assess motor, visual, and early language skills.

Sleep location, duration, quality, and interactions; validated for infants and toddlers through age 3 years; REDCap online. Scores range from 0-100 with higher scores representing healthier, more consolidated sleep patterns (e.g., shorter time to fall asleep, fewer and shorter night wakings).

Actigraphy is a standard, valid, noninvasive measure for assessing sleep and circadian rhythm patterns across the life course. For infants and young children (e.g., toddlers), the actigraph is a small watch-like device that will be worn around the left ankle to record body motion (activity counts). The child will wear the devices for 7 continuous days and nights after all in-home visits. Constant assessment is necessary to capture the full development of sleep-wake patterns and circadian rhythmicity across toddlerhood. Home visits will be scheduled to avoid current illnesses or well-visits to avoid vaccination effects on sleep patterns. Primary sleep variables will be averaged across the recording period. Data will be reported in minutes of time that the child is awake or asleep.

During actigraphy data collection, the parent/guardian will complete sleep diaries on the sleep of their toddler. Diaries will be used to identify artifacts that might affect motion (externally induced motion e.g. car seat, swing, or constricted motion e.g. swaddling), and to define sleep periods from actigraphy outputs for children prior to analysis with the sleep-wake algorithms. Primary sleep diary variables will be (1) bed/nap clock times attempted to sleep, (2) bed/nap clock times of sleep bout awakenings, and (3) time in bed or interval between attempted bed and wake times.

Research personnel will objectively evaluate the caring environment in which a child is raised and parent-child interaction using this validated assessment. The inventory qualitatively assesses the quality and extent of stimulation, support, and learning resources available in a child's home environment.

Habitual intake will be assessed via the Automated Self-Administered 24-hr recall software (ASA24) on 2 weekdays and one weekend day developed by the National Cancer Institute.

Pre-post meal photos of the infant and their food will be provided by the parents. These images will be used to help corroborate dietary intake and behavior data.

This questionnaire asks about breastfeeding, formula feeding, complementary feeding, introduction to solid foods, food allergies, and participation in the Special Supplemental Nutrition Assistance Program for Women, Infant, and Children.

The USDA 6-Item Food Security Screener will be used to assess household food insecurity. Scores range from 0-6 with higher scores representing higher levels of food insecurity.

Will be used to evaluate allergy exposures and risk across the study period. This is a checklist of various common allergies that parents report the child having or not having each allergy.

Parents will be asked to classify the stool consistency using the picture-based Brussels Infant and Toddler Stool Scale (BITSS), developed specifically for non-toilet-trained children.

To assess children's experiences of gastrointestinal and gastroesophageal reflux symptoms. A total score is calculated as a sum of responses from 36 questions. Higher scores indicate greater symptom burden, and scores range from 0 to 180