New Infant Formula Supports Adequate Growth in Healthy Infants

Not Applicable

• Conditions: Infant Development
• Interventions: Other: Formula B; Other: Formula A

• Registration Number: NCT03614468
• Lead Sponsor: Worthy Health

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-02-26
• Study Start: 2019-05-08
• Primary Completion: 2020-05-08
• Study Completion: 2020-05-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Weight gain change measured at set intervals for first 365 days	1-21 days, 42 days, 84 days, 126 days, 180 days, 270 days, 365 days	The infants will be weighed naked while lying quietly on a calibrated electronic scale accurate to 10 grams.

Secondary Outcome Measures

Name	Time	Method
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	1. Daily stool frequency; 2. Stool consistency (on a five-point scale: 1 = watery, 2 = soft/pudding like, 3 = soft formed, 4 = dry formed, 5 = dry/hard pellets); 3. Constipation (0 = absent, 1 = mild, 2 = moderate, 3 = severe); 4. Diarrhea (0 = absent, 1 = mild, 2 = moderate, 3 = severe); 5. Colic (0 = absent, 1 = mild, 2 = moderate, 3 = severe); 6. Vomiting (0 = absent, 1 = mild, 2 = moderate, 3 = severe); 7. Regurgitation (0 = absent, 1 = mild, 2 = moderate, 3 = severe); 8. Flatulence (0 = absent, 1 = mild, 2 = moderate, 3 = severe); 9. Nappy rash (0 = absent, 1 = mild, 2 = moderate, 3 = severe)