Infant Formula and Toddler Drink Feeding Intervention

NCT04495738 | Terminated

• 1 other identifier: AL38
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 27

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.

Conditions

Respiratory Infections in Children

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory infection between study groups

  Adverse event reports

  Study Day 1 to 6 Months of Age

Secondary Outcomes (1)

• Infection morbidity between study groups

  Study Day 1 to 24 Months of Age

Other Outcomes (21)

• Weight

  Study Day 1 to 24 Months of Age

• Length

  Study Day 1 to 24 Months of Age

• Head Circumference (HC)

  Study Day 1 to 24 Months of Age

Study Arms (3)

Control Feeding Group

ACTIVE COMPARATOR

Ready to feed milk-based product

Other: Control Infant Formula; Other: Control Toddler Drink

Experimental Feeding Group

EXPERIMENTAL

Ready to feed milk-based product with oligosaccharides

Other: Experimental Infant Formula; Other: Experimental Toddler Drink

Human Milk (HM) Reference Group

OTHER

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

Interventions

Control Infant Formula OTHER

Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age

Control Feeding Group

Control Toddler Drink OTHER

16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age

Control Feeding Group

Experimental Infant Formula OTHER

Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age

Experimental Feeding Group

Experimental Toddler Drink OTHER

16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age

Experimental Feeding Group

Supplemental Formula for HM Group OTHER

Ad libitum formula given up to 12 months of age if HM is supplemented

Human Milk (HM) Reference Group

Toddler Drink for HM group OTHER

16 fl oz per day if weaned from HM feedings

Human Milk (HM) Reference Group

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (27)

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

Location

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, 72401, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72019, United States

Location

Boeson Research 3266

Grand Junction, Colorado, 81505, United States

Location

TOPAZ Clinical Research, Inc.

Apopka, Florida, 32703, United States

Location

ASCLEPES Research Centers

Spring Hill, Florida, 34609, United States

Location

Meridian Clinical Research 3259

Macon, Georgia, 31210, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Qualmedica Research 3272

Evansville, Indiana, 47715, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47725, United States

Location

Qualmedica Research, LLC 3270

Owensboro, Kentucky, 42301, United States

Location

Meridian Clinical Research 3080

Baton Rouge, Louisiana, 70806, United States

Location

Boeson Research 3265

Kalispell, Montana, 59901, United States

Location

Boeson Research 3267

Missoula, Montana, 59804, United States

Location

Meridian Clinical Research 3264

Grand Island, Nebraska, 68803, United States

Location

Meridian Clinical Research 3263

Hastings, Nebraska, 68901, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

MultiCare Institute for Research & Innovation

Dickinson, Texas, 77539, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

PAS Research 3273

McAllen, Texas, 78501, United States

Location

Multicare Rockwood Pediatrics

Spokane, Washington, 99202, United States

Location

Mercury Clinical Research 3261

Tacoma, Washington, 98405, United States

Location

Study Officials

• Bridget Barrett Reis, PhD, RD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: August 10, 2020
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)