Growth
Conditions
Brief summary
The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.
Interventions
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
\ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
\ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
OTHERHuman Milk
Ad libitum or as instructed by HCP
OTHERHuman Milk Supplemental Formula
Ad libitum if consuming supplemented formula; feeding period up to 12 months of age
OTHERHuman Milk Toddler Drink
\ 16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Participant is judged to be in good health as determined from participant's medical history * Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks by parent report * Participant's birth weight was ≥ 2490 g (\ 5 lbs. 8 oz.) * Parent(s) confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life * Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage * Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study * Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP * Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study * If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age. * If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage.
Exclusion criteria
* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development * Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant * Suspected maternal substance abuse including alcohol * Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance * Participant is in another study that has not been approved as a concomitant study by AN * Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment * Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth | Study Day 1 to 6 Months of Age | weight for age z-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of respiratory infection episodes between study groups | Study Day 1 to 24 Months of Age | Adverse event reports |
| Incidence of infection morbidity between study groups | Study Day 1 to 24 Months of Age | Adverse event reports |
| Number of episodes of infection morbidity between study groups | Study Day 1 to 24 Months of Age | Adverse event reports |
| Incidence of respiratory infection between study groups | Study Day 1 to 24 Months of Age | Adverse event reports |
| Length | Study Day 1 to 24 Months of Age | Interval length gain per day |
| Head Circumference | Study Day 1 to 24 Months of Age | Interval head circumference gain per day |
| Gastrointestinal Tolerance | Study Day 1 to 12 months of Age | Parent completed diary |
| Weight | Study Day 1 to 24 Months of Age | Interval weight gain per day |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified Home Short Form | 6 Months of Age to 24 Months of Age] | Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups |
| Medications | Study Day 1 to 24 Months of Age | Medication usage including frequency and reason for use |
| Adverse Events | Study Day 1 to 24 Months of Age | Parent reported adverse events |
| Formula Satisfaction Questionnaire | 28 Days of Age to 6 Months of Age | Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative |
| Missed Parental Work Days | Study Day 1 to 24 Months of Age | Parent reported number of days |
| Blood Collection | 6 and 24 Months of Age | Blood Immune Markers; Subset of subjects |
| Health Resource Utilization | Study Day 1 to 24 Months of Age | Number of visits |
| Toddler Drink Satisfaction Questionnaire | 18 Months of Age to 24 Months of Age | Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative |
| Infant Feeding and Stool Patterns Questionnaire | 28 Days of Age to 119 Days of Age] | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from Always to Never |
| Infant and Toddler Behavior Questionnaire | 119 Days of Age | Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled from Always to Never |
| Product Intake | Study Day 1 to 24 Months of Age | Parent completed intake diary |
| Dietary Intake | 6 Months of Age to 24 Months of Age | Parent completed 24-hour recall |
| Stool Sample | Study Day 1 to 24 Months of Age | Microbiota characterization; Subset of subjects |
| Bayley™-4 Scale of Infant & Toddler Development IV | 12 Months of Age to 24 Months of Age | Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups; Subset of subjects |
| MacArthur Communicative Developmental Inventory (CDI)/Words and Gestures and CDI)/Words and Sentences | 12 Months of Age to 24 Months of Age | Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups |
Countries
United States
Outcome results
None listed