Infant Formula and Toddler Drink Feeding Intervention

Respiratory Infections in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04495738
• Other study ID #: AL38
• Status: Terminated
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: April 12, 2021

Study information

• Verified date: May 2021
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 168
• Est. completion date: April 12, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A 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
• 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

Related Conditions & MeSH terms

• Respiratory Infections in Children
• Respiratory Tract Infections

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
• Supplemental Formula for HM Group
Ad libitum formula given up to 12 months of age if HM is supplemented
• Toddler Drink for HM group
16 fl oz per day if weaned from HM feedings

Locations

Country	Name	City	State
United States	TOPAZ Clinical Research, Inc.	Apopka	Florida
United States	Meridian Clinical Research 3080	Baton Rouge	Louisiana
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	MultiCare Institute for Research & Innovation	Dickinson	Texas
United States	Southeastern Pediatric Associates	Dothan	Alabama
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Qualmedica Research 3272	Evansville	Indiana
United States	Meridian Clinical Research 3264	Grand Island	Nebraska
United States	Boeson Research 3266	Grand Junction	Colorado
United States	Cyn3rgy Research	Gresham	Oregon
United States	Meridian Clinical Research 3263	Hastings	Nebraska
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	Kingsport	Tennessee
United States	Maximos Ob/Gyn	League City	Texas
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Meridian Clinical Research 3259	Macon	Georgia
United States	PAS Research 3273	McAllen	Texas
United States	Boeson Research 3267	Missoula	Montana
United States	Qualmedica Research, LLC 3270	Owensboro	Kentucky
United States	Multicare Rockwood Pediatrics	Spokane	Washington
United States	ASCLEPES Research Centers	Spring Hill	Florida
United States	Mercury Clinical Research 3261	Tacoma	Washington
United States	Eclipse Clinical Research	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Weight in grams	Study Day 1 to 24 Months of Age
Other	Length	Length in cm	Study Day 1 to 24 Months of Age
Other	Head Circumference (HC)	HC in cm	Study Day 1 to 24 Months of Age
Other	Gastrointestinal Tolerance	Parent completed diary	Study Day 1 to 119 Days of Age
Other	Dietary Intake	Parent completed diary	Study Day 1 to 24 Months of Age
Other	Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction	28 Days of Age to 119 Days of Age
Other	Infant Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction	119 Days of Age
Other	Formula Satisfaction Questionnaire	Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction	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 in the negative direction	15 Months of Age to 24 Months of Age
Other	Human Milk Sample	Oligosaccharide characterization	84 Days of Age
Other	Stool Sample	Microbiota characterization	Study Day 1 to 24 Months of Age
Other	Saliva Sample	Maternal-Infant secretor status	84 Days 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	Behavioral Questionnaire	Parent completed questionnaire; 8 questions related to sleep, physical activity and screen time	12 Months of Age to 24 Months of Age
Other	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	6 Months of Age to 18 Months of Age
Other	Bayley Scale of Infant & Toddler Development	Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups	12 Months of Age to 24 Months of Age
Other	MacArthur Communicative Developmental Inventory	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	Edinburgh Postnatal Depression Scale	Mother completed questionnaire; Scores for each of the 10 items are totaled; Higher scores indicate more depressive symptoms	28 Days of Age
Other	Medications	Medication usage including frequency and reason for use	Study Day 1 to 24 Months of Age
Other	Adverse Events	Standard Adverse Event reporting	Study Day 1 to 24 Months of Age
Other	Health Resource Utilization	Number of visits	Study Day 1 to 24 Months of Age
Primary	Incidence of respiratory infection between study groups	Adverse event reports	Study Day 1 to 6 Months of Age
Secondary	Infection morbidity between study groups	Adverse event reports	Study Day 1 to 24 Months of Age