Growth and Safety Study of an Infant Formula for Healthy Term Infants

NCT ID: NCT03331276

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2019-01-07

Brief Summary

A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.

Detailed Description

This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a experimental infant formula, formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks; infant growth, serum markers for inflammation and tolerance to the formulas will be assessed throughout the study.

Conditions

Infant Development

Study Design

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

Study Groups

BBN

An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age with high Sn-2 Palmitate, Alpha Lactalbumin and Osteopontin to better mimic human milk.

Group Type: EXPERIMENTAL

BBN

Intervention Type: OTHER

BBN to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.

Brand

A Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron)

Group Type: ACTIVE_COMPARATOR

Brand

Intervention Type: OTHER

Brand to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.

Interventions

BBN

BBN to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.

Intervention Type: OTHER

Brand

Brand to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.

Intervention Type: OTHER

Other Intervention Names

BBN-001; Enfamil

Eligibility Criteria

Inclusion Criteria

• Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:

1. Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant

2. Have a birth weight of ≥ 2500 grams

At the time of the baseline/enrollment visit, infants must be:

3. Designated as healthy by a physician

4. ≤14 days post-natal age (Date of Birth = Day 0)

5. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts

6. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts

7. Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts

8. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts

9. Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment; only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole soure of nutrition, will be approached for potential study enrollment

10. Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study

11. Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study.

Exclusion Criteria

Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula:

1. Show evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician);

2. Show evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases;

3. Have a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is < 4300 g), active tuberculosis, perinatal infection, or substance abuse

4. Have a family history of cow's milk protein intolerance/allergy

5. Are an infant from a multiple birth (twin, triplet, etc.) -

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Paidion Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Building Block Nutritionals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie Dunn, MD

Role: STUDY_DIRECTOR

Paidion Research, Inc.

Locations

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Southeastern Pediatric Associates

Dothan, Alabama, United States

Norwich Pediatric Group

Norwich, Connecticut, United States

Aventiv Research

Grove City, Ohio, United States

HMG Pediatrics at Medical Plaza

Bristol, Tennessee, United States

Jackson Clinic

Jackson, Tennessee, United States

Countries

United States

References

Yao M, Lien EL, Capeding MR, Fitzgerald M, Ramanujam K, Yuhas R, Northington R, Lebumfacil J, Wang L, DeRusso PA. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):440-8. doi: 10.1097/MPG.0000000000000443.

Reference Type: RESULT

PMID: 24840511 (View on PubMed)

Other Identifiers

BBN-IF-001

Identifier Type: -

Identifier Source: org_study_id