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

Not Applicable

Completed

• Conditions: Infant Development
• Interventions: Other: BBN; Other: Brand

• Registration Number: NCT03331276
• Lead Sponsor: Building Block Nutritionals, LLC

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.

Study Timeline

• Study Start: 2017-09-18
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Primary Completion: 2019-01-07
• Study Completion: 2019-01-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.) -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Weight gain	16 weeks	g/d

Secondary Outcome Measures

Name	Time	Method
Mean interleukin - 6 Concentration	at 16 weeks	IL - 6 ng/ml
Mean interleukin - 10 Concentration	at 16 weeks	IL - 10 pg/ml
Mean stool consistency	Monthly for 16 weeks	1= watery, 2= runny / soft, 3= musy / soft, 4= formed soft, 5= hard
Mean fussiness score	Monthly 16 weeks	0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal
Mean gassiness score	Monthly 16 weeks	0= no gas, 1= slight amount of gas, 2= moderate amout of gas, 3= excessive amount of gas
Mean tumor necrosis factor alpha Concentration	at 16 weeks	TNF - alpha pg/ml

Trial Locations

Locations (6)

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

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States