New Infant Formula Supports Adequate Growth and Safety Study in Healthy Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant Development
- Sponsor
- Worthy Health
- Enrollment
- 80
- Primary Endpoint
- Weight gain change measured at set intervals for first 365 days
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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
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:
- •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.
Outcomes
Primary Outcomes
Weight gain change measured at set intervals for first 365 days
Time Frame: 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 Outcomes
- 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)