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

Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218929
• Other study ID #: SS-101-18
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: June 11, 2021

Study information

• Verified date: June 2021
• Source: ByHeart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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.

Related Conditions & MeSH terms

• Infants
• Newborn

Intervention

Other:
• Study Formula (SF)
New infant formula for term infants fed ad lib
• Comparator Formula (CF)
Commercially available infant formula for term infants fed ad lib

Locations

Country	Name	City	State
United States	Topaz Clinical Research	Apopka	Florida
United States	San Gabriel Women's Health	Arcadia	California
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	HMG Primary Care at Sapling Grove	Bristol	Tennessee
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Pediatric Associates of Mt. Carmel, Inc	Cincinnati	Ohio
United States	Optum	Colorado Springs	Colorado
United States	Schear Family Practice	Dayton	Ohio
United States	Pediatric Associates of Fairfield, Inc.	Fairfield	Ohio
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Houston Clinical Research Associates	Houston	Texas
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Jackson Clinic North	Jackson	Tennessee
United States	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas
United States	HMG Pediatrics at Kingsport	Kingsport	Tennessee
United States	Sierra Clinical Research	Las Vegas	Nevada
United States	Tanner Clinic	Layton	Utah
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Institute of Clinical Research	Mentor	Ohio
United States	Avanza Medical Research	Pensacola	Florida
United States	ACRC Trials Plano Pediatrics	Plano	Texas
United States	Northern California Research	Sacramento	California
United States	Coastal Pediatric Associates	Summerville	South Carolina
United States	PAS-Research	Tampa	Florida
United States	Watching Over Mothers and Babies	Tucson	Arizona
United States	Southern Clinical Research	Zachary	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
ByHeart	Paidion Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain Velocity	G/D	0 - 16 weeks
Secondary	Weight Measures	KG	0 - 16 weeks
Secondary	Length Measures	CM	0 - 16 weeks
Secondary	Length Gain Velocity	CM/D	0 - 16 weeks
Secondary	Head Circumference Measures	CM	0 - 16 weeks
Secondary	Weight for age Z-scores	Weight for age Z-scores compared to World Health Organization (WHO) growth standards	0 - 16 weeks
Secondary	Length for age Z-scores	Length for age Z-scores compared to WHO growth standards	0 - 16 weeks
Secondary	Head circumference for age Z-scores	Head circumference for age Z-scores compared to WHO growth standards	0 - 16 weeks
Secondary	Weight for length Z-scores	Weight for length Z-scores compared to WHO growth standards	0 - 16 weeks
Secondary	72-hr record of formula intake at each study visit	OZ/D	0 - 16 weeks
Secondary	Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)	Concentration	16 weeks
Secondary	Blood concentrations of amino acids (umol/L)	Concentration	16 weeks
Secondary	Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals	Concentration	3 weeks, 7 weeks
Secondary	Medically-diagnosed adverse events collected throughout the study period	Frequency	0 through 16 weeks
Secondary	Parent rating of infant stool consistency at each study visit	Mean. Quinlan et al Likert scale; 0=no bowel movement, 1=hard [dry hard pellets], 2=formed [definite shape, not dry], 3=soft [no definite shape, pasty], 4=loose [no shape, some water], 5=watery [no shape, mainly water]).	0 - 16 weeks
Secondary	Parent report of infant stool frequency at each study visit	Mean	0 - 16 weeks
Secondary	Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit	Mean	0 - 16 weeks
Secondary	Stool microbiome	Fecal microbial taxa and community abundance	2 weeks, 16 weeks
Secondary	Stool metabolome	Targeted and Untargeted Metabolomics	2 weeks, 16 weeks