Growth and Tolerance of Infants Fed Milk-Based Infant Formula

NCT03967132 | Completed

• 1 other identifier: AL29A
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 19

Brief Summary

The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

Conditions

Gastro-Intestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight gain per day

  Day of life 14 - 119

Secondary Outcomes (5)

• Stool Characteristics

  Study Day 1 to Day of life 119

• Formula Tolerance

  Study Day 1 to Day of life 119

• Length

  Study Day 1 to Day of life 119

• Head Circumference (HC)

  Study Day 1 to Day of life 119

• Illness Incidence

  Study Day 1 to Day of life 119

Other Outcomes (1)

• Stool Sample

  Study Day 1 to Day of life 119

Study Arms (3)

Control Infant Formula

ACTIVE COMPARATOR

Milk-based infant formula

Other: Control Infant Formula

Experimental Infant Formula

EXPERIMENTAL

Milk-based Infant Formula with oligosaccharides

Other: Experimental Infant Formula

Reference Group

OTHER

Human-milk fed

Other: Reference Group

Interventions

Control Infant Formula OTHER

Ready to feed infant formula, feed ad libitum

Control Infant Formula

Experimental Infant Formula OTHER

Ready to feed infant formula, feed ad libitum

Experimental Infant Formula

Reference Group OTHER

Human milk, breast feeding ad libitum

Reference Group

Eligibility Criteria

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

You may qualify if:

• Good health as determined from participant's medical history
• Singleton from a full-term birth with a gestational age of 37-42 weeks
• Birth weight was \> 2490 g (\~5 lbs. 8 oz.)
• If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
• If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided 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 taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
• Participant participates in another study that has not been approved as a concomitant study by AN.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (19)

Watching Over Mothers & Babies

Tucson, Arizona, 85712, United States

Location

Pediatric Medical Associates

Sacramento, California, 95815, United States

Location

Norwich Pediatric Group, P.C.

Norwich, Connecticut, 06360, United States

Location

Phoenix Medical Research LLC

Miami, Florida, 33165, United States

Location

University Clinical Research-Deland, LLC a/b/a Accel Clinical Research

Orlando, Florida, 32829, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47725, United States

Location

Michael W. Simon, M.D., PSC

Nicholasville, Kentucky, 40356, United States

Location

Springs Medical Research

Owensboro, Kentucky, 42303, United States

Location

Institute of Clinical Research, LLC

Mentor, Ohio, 44060, United States

Location

The Cleveland Pediatric Research Center, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Midsouth Center for Clinical Research

Memphis, Tennessee, 38116, United States

Location

ARC Clinical Research at Wilson Parke

Austin, Texas, 78726, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Ventavia Research Group

Houston, Texas, 77008, United States

Location

Ventavia Research Group, LLC 3078

Keller, Texas, 76248, United States

Location

Kagan Pediatrics - HD Research Corporation

Pearland, Texas, 77584, United States

Location

Plano Pediatrics - ACRC Trials

Plano, Texas, 75093, United States

Location

Study Officials

• Timberly Williams, PhD

  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: May 27, 2019
• First Posted: May 30, 2019
• Study Start: June 8, 2019
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)