New Infant Formula Supports Adequate Growth in Healthy Infants

NCT03614468 | Unknown DMC

• 1 other identifier: 79105203
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study is to evaluate the growth, safety, and tolerance in healthy, term infants consuming a new to market infant formula (Formula A) and a commercially available infant formula (Formula B) with daily weight gain as the primary outcome. As secondary outcomes, the study will evaluate other growth parameters, tolerance, and safety.

Conditions

Infant Development

Keywords

Infant Formula

Outcome Measures

Primary Outcomes (1)

• Weight gain change measured at set intervals for first 365 days

  The infants will be weighed naked while lying quietly on a calibrated electronic scale accurate to 10 grams.

  1-21 days, 42 days, 84 days, 126 days, 180 days, 270 days, 365 days

Secondary Outcomes (1)

• Safety and Tolerability evaluated and recorded by parents in daily journal on stool observations at start through 365 days using VAS (Visual Analogue Scale)

  Daily through 365 days

Study Arms (2)

Formula A

EXPERIMENTAL

An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age.

Other: Formula A

Formula B

ACTIVE COMPARATOR

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

Other: Formula B

Interventions

Formula A OTHER

Formula A is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.

Formula A

Formula B OTHER

Formula B is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.

Formula B

Eligibility Criteria

• Age: 1 Day - 21 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:
• Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole source of nutrition, will be approached for potential study enrollment
• Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
• Have a birth weight of ≥ 2500 grams
• At the time of the baseline/enrollment visit, infants must be:
• Designated as healthy by a physician
• ≤21 days post-natal age (Date of Birth = Day 0)
• Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment
• 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
• 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.

You may not qualify if:

• 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:
• Infants showing evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician)
• Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases
• Having 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,
• Having a family history of cow's milk protein intolerance/allergy
• Are an infant from a multiple birth (twin, triplet, etc.)
• Mothers who smoked cigarettes
• Mothers who used illicit drugs during pregnancy.

Sponsors & Collaborators

• Worthy Health: lead

Related Publications (7)

• Field CJ. The immunological components of human milk and their effect on immune development in infants. J Nutr. 2005 Jan;135(1):1-4. doi: 10.1093/jn/135.1.1.

  PMID: 15623823 RESULT

• Garcia C, Duan RD, Brevaut-Malaty V, Gire C, Millet V, Simeoni U, Bernard M, Armand M. Bioactive compounds in human milk and intestinal health and maturity in preterm newborn: an overview. Cell Mol Biol (Noisy-le-grand). 2013 Dec 30;59(1):108-31.

  PMID: 25326648 RESULT

• Jost T, Lacroix C, Braegger C, Chassard C. Impact of human milk bacteria and oligosaccharides on neonatal gut microbiota establishment and gut health. Nutr Rev. 2015 Jul;73(7):426-37. doi: 10.1093/nutrit/nuu016. Epub 2015 Apr 15.

  PMID: 26081453 RESULT

• Koletzko B, Baker S, Cleghorn G, Neto UF, Gopalan S, Hernell O, Hock QS, Jirapinyo P, Lonnerdal B, Pencharz P, Pzyrembel H, Ramirez-Mayans J, Shamir R, Turck D, Yamashiro Y, Zong-Yi D. Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):584-99. doi: 10.1097/01.mpg.0000187817.38836.42.

  PMID: 16254515 RESULT

• Verwimp JJ, Bindels JG, Barents M, Heymans HS. Symptomatology and growth in infants with cow's milk protein intolerance using two different whey-protein hydrolysate based formulas in a Primary Health Care setting. Eur J Clin Nutr. 1995 Sep;49 Suppl 1:S39-48.

  PMID: 8647062 RESULT

• Szajewska H, Chmielewska A. Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials. BMC Pediatr. 2013 Nov 12;13:185. doi: 10.1186/1471-2431-13-185.

  PMID: 24215626 RESULT

• Saha KK, Frongillo EA, Alam DS, Arifeen SE, Persson LA, Rasmussen KM. Use of the new World Health Organization child growth standards to describe longitudinal growth of breastfed rural Bangladeshi infants and young children. Food Nutr Bull. 2009 Jun;30(2):137-44. doi: 10.1177/156482650903000205.

  PMID: 19689092 RESULT

Study Officials

• Fred Worthy

  Chairman, Worthy Health

  STUDY DIRECTOR

Central Study Contacts

Fred Worthy

CONTACT

310 487-9971; fred@worthy-health.com

Anthony Worthy

CONTACT

310 367 0004; anthony@worthy-health.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Formula feed infants will be randomized to receive either a new infant formula formulated for healthy term infants (Formula A) or a commercially available infant formula for healthy term infants (Formula B). Infants will consume the formula for a total of 52-weeks.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 3, 2018
• Study Start: May 8, 2019
• Primary Completion: May 8, 2020
• Study Completion: May 25, 2020
• Last Updated: February 26, 2019

Record last verified: 2019-02