New Infant Formula Supports Adequate Growth in Healthy Infants

Infant Development Clinical Trial

Official title:

New Infant Formula Supports Adequate Growth and Safety Study in Healthy Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03614468
• Other study ID #: 79105203
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: May 25, 2020

Study information

• Verified date: February 2019
• Source: Worthy Health
• Contact: Fred Worthy
• Phone: 310 487-9971
• Email: fred[@]worthy-health.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a controlled randomized parallel assignment, masked (Participant, Care Provider, Investigator, Outcomes Assessor) study. Healthy infants will be assigned an Investigational (Formula A) experimental new milk based infant formula, or an active comparator Control (Formula B) Enfamil (trademark brand name) marketed milk based infant formula. The period for the study is 365 days (52 weeks) using repeated-measures mixed model (RMMM). Anthropometry, formula intake, tolerance, and stool characteristics will be assessed. Medically confirmed adverse events will be recorded throughout the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 25, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Days

Eligibility

Inclusion Criteria:

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

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:

1. Designated as healthy by a physician

2. =21 days post-natal age (Date of Birth = Day 0)

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

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

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

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

7. Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment

8. 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

9. 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. Infants showing evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician)

2. Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases

3. 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,

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

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

6. Mothers who smoked cigarettes

7. Mothers who used illicit drugs during pregnancy.

Related Conditions & MeSH terms

• Infant Development

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Worthy Health

References & 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. Review. — View Citation

Garcia C, Duan RD, Brévaut-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. Review. — View Citation

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. Review. — View Citation

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 — View Citation

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) — View Citation

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. Review. — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 stool frequency; Stool consistency (on a five-point scale: 1 = watery, 2 = soft/pudding like, 3 = soft formed, 4 = dry formed, 5 = dry/hard pellets); Constipation (0 = absent, 1 = mild, 2 = moderate, 3 = severe); Diarrhea (0 = absent, 1 = mild, 2 = moderate, 3 = severe); Colic (0 = absent, 1 = mild, 2 = moderate, 3 = severe); Vomiting (0 = absent, 1 = mild, 2 = moderate, 3 = severe); Regurgitation (0 = absent, 1 = mild, 2 = moderate, 3 = severe); Flatulence (0 = absent, 1 = mild, 2 = moderate, 3 = severe); Nappy rash (0 = absent, 1 = mild, 2 = moderate, 3 = severe)	Daily through 365 days