Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

NCT ID: NCT04218929

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2021-06-11

Brief Summary

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

Conditions

Infants; Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Study Formula (SF)

New infant formula for term infants

Group Type: EXPERIMENTAL

Study Formula (SF)

Intervention Type: OTHER

New infant formula for term infants fed ad lib

Comparator Formula (CF)

Commercially available infant formula for term infants

Group Type: ACTIVE_COMPARATOR

Comparator Formula (CF)

Intervention Type: OTHER

Commercially available infant formula for term infants fed ad lib

Human Milk Reference Group

Human milk

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Study Formula (SF)

New infant formula for term infants fed ad lib

Intervention Type: OTHER

Comparator Formula (CF)

Commercially available infant formula for term infants fed ad lib

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
• Birth weight of greater than or equal to 2500 grams.
• Designated healthy by a physician.
• Less than or equal to 14 days of age at enrollment.
• If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
• If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
• Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
• Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
• Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
• Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.

Exclusion Criteria

• Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
• Infants required to take medications know to influence growth and development.
• Maternal history with known adverse effects on the fetus and/or the newborn infants.
• Family history of cow milk protein allergy or soy intolerance/allergy.
• Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
• Infants from a multiple birth.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Paidion Research, Inc.

INDUSTRY

Sponsor Role: collaborator

ByHeart

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Devon Kuehn, MD

Role: STUDY_DIRECTOR

ByHeart, Inc.

Locations

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Watching Over Mothers and Babies

Tucson, Arizona, United States

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

Jonesboro, Arkansas, United States

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

San Gabriel Women's Health

Arcadia, California, United States

Northern California Research

Sacramento, California, United States

Optum

Colorado Springs, Colorado, United States

Topaz Clinical Research

Apopka, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Avanza Medical Research

Pensacola, Florida, United States

PAS-Research

Tampa, Florida, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Southern Clinical Research

Zachary, Louisiana, United States

Sierra Clinical Research

Las Vegas, Nevada, United States

Pediatric Associates of Mt. Carmel, Inc

Cincinnati, Ohio, United States

Schear Family Practice

Dayton, Ohio, United States

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, United States

Institute of Clinical Research

Mentor, Ohio, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

Coastal Pediatric Associates

Summerville, South Carolina, United States

HMG Primary Care at Sapling Grove

Bristol, Tennessee, United States

Jackson Clinic North

Jackson, Tennessee, United States

HMG Pediatrics at Kingsport

Kingsport, Tennessee, United States

Houston Clinical Research Associates

Houston, Texas, United States

DCOL Center for Clinical Research

Longview, Texas, United States

ACRC Trials Plano Pediatrics

Plano, Texas, United States

Tanner Clinic

Layton, Utah, United States

Countries

United States

References

Kuehn D, Zeisel SH, Orenstein DF, German JB, Field CJ, Teerdhala S, Knezevic A, Patil S, Donovan SM, Lonnerdal B. Effects of a Novel High-Quality Protein Infant Formula on Energetic Efficiency and Tolerance: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2022 Oct 1;75(4):521-528. doi: 10.1097/MPG.0000000000003490. Epub 2022 Jun 6.

Reference Type: DERIVED

PMID: 35666855 (View on PubMed)

Other Identifiers

SS-101-18

Identifier Type: -

Identifier Source: org_study_id