An interventional study of Control Infant Formula and Control Toddler Drink in Respiratory Infections in Children, sponsored by Abbott Nutrition. Terminated at 27 sites in United States. Open to participants aged Up to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-14.
Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 168 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ready to feed milk-based product
Other: Control Infant Formula · Other: Control Toddler Drink
Ready to feed milk-based product with oligosaccharides
Other: Experimental Infant Formula · Other: Experimental Toddler Drink
HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product
Other: Supplemental Formula for HM Group · Other: Toddler Drink for HM group
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
Ad libitum formula given up to 12 months of age if HM is supplemented
16 fl oz per day if weaned from HM feedings
Incidence of respiratory infection between study groups
Adverse event reports
Time frame: Study Day 1 to 6 Months of Age
Infection morbidity between study groups
Adverse event reports
Time frame: Study Day 1 to 24 Months of Age
Weight
Weight in grams
Time frame: Study Day 1 to 24 Months of Age
Length
Length in cm
Time frame: Study Day 1 to 24 Months of Age
Head Circumference (HC)
HC in cm
Time frame: Study Day 1 to 24 Months of Age
Gastrointestinal Tolerance
Parent completed diary
Time frame: Study Day 1 to 119 Days of Age
Dietary Intake
Parent completed diary
Time frame: Study Day 1 to 24 Months of Age
Infant Feeding and Stool Patterns Questionnaire
Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction
Time frame: 28 Days of Age to 119 Days of Age
Infant Behavior Questionnaire
Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction
Time frame: 119 Days of Age
Formula Satisfaction Questionnaire
Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction
Time frame: 28 Days of Age to 6 Months of Age
Toddler Drink Satisfaction Questionnaire
Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction
Time frame: 15 Months of Age to 24 Months of Age
Human Milk Sample
Oligosaccharide characterization
Time frame: 84 Days of Age
Stool Sample
Microbiota characterization
Time frame: Study Day 1 to 24 Months of Age
Saliva Sample
Maternal-Infant secretor status
Time frame: 84 Days of Age
Modified Home Short Form
Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups
Time frame: 6 Months of Age to 24 Months of Age
Behavioral Questionnaire
Parent completed questionnaire; 8 questions related to sleep, physical activity and screen time
Time frame: 12 Months of Age to 24 Months of Age
Ages & Stages Questionnaire
Parent completed questionnaire; 5 Developmental areas; Scores to the six questions in each area are totaled; Higher scores indicate more positive outcomes
Time frame: 6 Months of Age to 18 Months of Age
Bayley Scale of Infant & Toddler Development
Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups
Time frame: 12 Months of Age to 24 Months of Age
MacArthur Communicative Developmental Inventory
Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups
Time frame: 12 Months of Age to 24 Months of Age
Edinburgh Postnatal Depression Scale
Mother completed questionnaire; Scores for each of the 10 items are totaled; Higher scores indicate more depressive symptoms
Time frame: 28 Days of Age
Medications
Medication usage including frequency and reason for use
Time frame: Study Day 1 to 24 Months of Age
Adverse Events
Standard Adverse Event reporting
Time frame: Study Day 1 to 24 Months of Age
Health Resource Utilization
Number of visits
Time frame: Study Day 1 to 24 Months of Age
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Abbott Nutrition