Respiratory Infections in Children
Conditions
Brief summary
The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children 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
OTHERSupplemental Formula for HM Group
Ad libitum formula given up to 12 months of age if HM is supplemented
OTHERToddler Drink for HM group
16 fl oz per day if weaned from HM feedings
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
No minimum 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 * Participant's birth weight was ≥ 2490 g (\ 5 lbs. 8 oz.) * If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life * If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage * If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age * If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage * Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study * Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age * 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.
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 * Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, 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 * Participant has been treated with antibiotics prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of respiratory infection between study groups | Study Day 1 to 6 Months of Age | Adverse event reports |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection morbidity between study groups | Study Day 1 to 24 Months of Age | Adverse event reports |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length | Study Day 1 to 24 Months of Age | Length in cm |
| Head Circumference (HC) | Study Day 1 to 24 Months of Age | HC in cm |
| Gastrointestinal Tolerance | Study Day 1 to 119 Days of Age | Parent completed diary |
| Dietary Intake | Study Day 1 to 24 Months of Age | Parent completed diary |
| 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 in the negative direction |
| Infant Behavior Questionnaire | 119 Days of Age | Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction |
| Toddler Drink Satisfaction Questionnaire | 15 Months of Age to 24 Months of Age | Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction |
| Human Milk Sample | 84 Days of Age | Oligosaccharide characterization |
| Stool Sample | Study Day 1 to 24 Months of Age | Microbiota characterization |
| Formula Satisfaction Questionnaire | 28 Days of Age to 6 Months of Age | Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction |
| 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 |
| Behavioral Questionnaire | 12 Months of Age to 24 Months of Age | Parent completed questionnaire; 8 questions related to sleep, physical activity and screen time |
| Ages & Stages Questionnaire | 6 Months of Age to 18 Months of Age | Parent completed questionnaire; 5 Developmental areas; Scores to the six questions in each area are totaled; Higher scores indicate more positive outcomes |
| Bayley Scale of Infant & Toddler Development | 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 |
| MacArthur Communicative Developmental Inventory | 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 |
| Edinburgh Postnatal Depression Scale | 28 Days of Age | Mother completed questionnaire; Scores for each of the 10 items are totaled; Higher scores indicate more depressive symptoms |
| 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 | Standard Adverse Event reporting |
| Health Resource Utilization | Study Day 1 to 24 Months of Age | Number of visits |
| Saliva Sample | 84 Days of Age | Maternal-Infant secretor status |
| Weight | Study Day 1 to 24 Months of Age | Weight in grams |
Countries
United States
Outcome results
None listed