Infant Formula and Toddler Drink Feeding Study

Growth Clinical Trial

Official title:

Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04957992
• Other study ID #: AL51
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 637
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• Control Infant Formula
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
• Control Toddler Drink
~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
• Experimental Infant Formula
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
• Experimental Toddler Drink
~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
• Human Milk
Ad libitum or as instructed by HCP
• Human Milk Supplemental Formula
Ad libitum if consuming supplemented formula; feeding period up to 12 months of age
• Human Milk Toddler Drink
~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age

Locations

Country	Name	City	State
United States	TOPAZ Clinical Research, Inc.	Apopka	Florida
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Holston Medical Group 3301	Bristol	Tennessee
United States	Advantage Clinical Trials	Bronx	New York
United States	Optumcare Colorado Springs, LLC	Colorado Springs	Colorado
United States	MedPharmics, LLC 3343	Covington	Louisiana
United States	Javara Inc. 3377	Dallas	Texas
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Qualmedica Research	Evansville	Indiana
United States	HealthStar Research	Glenwood	Arkansas
United States	Meridian Clinical Research 3264	Grand Island	Nebraska
United States	Boeson Research 3266	Grand Junction	Colorado
United States	Boeson Research 3367	Great Falls	Montana
United States	Tribe Clinical Research LLC 3313	Greenville	South Carolina
United States	Meridian Clinical Research 3263	Hastings	Nebraska
United States	HealthStar Research, LLC	Hot Springs	Arkansas
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Leavitt Clinical Research	Idaho Falls	Idaho
United States	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas
United States	Boeson Research 3265	Kalispell	Montana
United States	Holston Medical Group 3046	Kingsport	Tennessee
United States	Maximos Ob/Gyn	League City	Texas
United States	Alivation Research	Lincoln	Nebraska
United States	Meridian Clinical Research 3304	Lincoln	Nebraska
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Meridian Clinical Research 3259	Macon	Georgia
United States	AVIATI Healthcare & Clinical Research	Memphis	Tennessee
United States	Columbus Clinical Services, LLC.	Miami	Florida
United States	Boeson Research 3267	Missoula	Montana
United States	University of Nebraska Medical Center 3314	Omaha	Nebraska
United States	University of Nebraska Medical Center 3315	Omaha	Nebraska
United States	Qualmedica Research, LLC	Owensboro	Kentucky
United States	Emerald Coast OBGYN Clinical Research	Panama City	Florida
United States	MedPharmics, LLC 3192	Phoenix	Arizona
United States	National Clinical Research, Inc	Richmond	Virginia
United States	MedPharmics Research 3369	Slidell	Louisiana
United States	Tribe Clinical Research LLC 3382	Spartanburg	South Carolina
United States	Multicare Health System - Rockwood Pediatrics	Spokane	Washington
United States	ASCLEPES Research Centers	Spring Hill	Florida
United States	Coastal Pediatric Research	Summerville	South Carolina
United States	Jedidiah Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Formula Satisfaction Questionnaire	Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative	28 Days of Age to 6 Months of Age
Other	Toddler Drink Satisfaction Questionnaire	Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative	18 Months of Age to 24 Months of Age
Other	Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from Always to Never	28 Days of Age to 119 Days of Age]
Other	Infant and Toddler Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled from Always to Never	119 Days of Age
Other	Product Intake	Parent completed intake diary	Study Day 1 to 24 Months of Age
Other	Dietary Intake	Parent completed 24-hour recall	6 Months of Age to 24 Months of Age
Other	Stool Sample	Microbiota characterization; Subset of subjects	Study Day 1 to 24 Months of Age
Other	Bayley™-4 Scale of Infant & Toddler Development IV	Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups; Subset of subjects	12 Months of Age to 24 Months of Age
Other	MacArthur Communicative Developmental Inventory (CDI)/Words and Gestures and CDI)/Words and Sentences	Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups	12 Months of Age to 24 Months of Age
Other	Modified Home Short Form	Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups	6 Months of Age to 24 Months of Age]
Other	Medications	Medication usage including frequency and reason for use	Study Day 1 to 24 Months of Age
Other	Adverse Events	Parent reported adverse events	Study Day 1 to 24 Months of Age
Other	Health Resource Utilization	Number of visits	Study Day 1 to 24 Months of Age
Other	Missed Parental Work Days	Parent reported number of days	Study Day 1 to 24 Months of Age
Other	Blood Collection	Blood Immune Markers; Subset of subjects	6 and 24 Months of Age
Primary	Growth	weight for age z-score	Study Day 1 to 6 Months of Age
Secondary	Incidence of respiratory infection between study groups	Adverse event reports	Study Day 1 to 24 Months of Age
Secondary	Number of respiratory infection episodes between study groups	Adverse event reports	Study Day 1 to 24 Months of Age
Secondary	Incidence of infection morbidity between study groups	Adverse event reports	Study Day 1 to 24 Months of Age
Secondary	Number of episodes of infection morbidity between study groups	Adverse event reports	Study Day 1 to 24 Months of Age
Secondary	Weight	Interval weight gain per day	Study Day 1 to 24 Months of Age
Secondary	Length	Interval length gain per day	Study Day 1 to 24 Months of Age
Secondary	Head Circumference	Interval head circumference gain per day	Study Day 1 to 24 Months of Age
Secondary	Gastrointestinal Tolerance	Parent completed diary	Study Day 1 to 12 months of Age