Healthy Growth
Conditions
Keywords
infant formula, cow milk, growth
Brief summary
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.
Detailed description
A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
Interventions
Powder, standard commercial infant formula.
OTHEROrganic Infant Formula
Powder, organic milk-based infant formula.
Sponsors
Paidion Research, Inc.
Nara Organics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A controlled, decentralized, double-blind trial of healthy, term, formula-fed infants randomized to one of two infant formulas: Control Formula (a standard, commercially available infant formula) or Investigational Formula for 16 weeks.
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days). * Birth weight of ≥ 2,500 g and ≤ 4,500 g. * Postnatal age ≤ 14 days. * Singleton. * Designated as healthy, that is no recognized diseases. * Weight, length, weight-for-length, and head circumference within ≥ 5th and ≤ 95th percentile for age-sex according to World Health Organization (WHO) growth standards (birth to 24 months). * Exclusive feeding and tolerating cow milk formula at time of enrollment. * Parent(s) or legal guardians are willing and able to feed the assigned formula as sole source of nutrition. * Parent(s) or legal guardians are willing and able to participate in anthropometric procedures. * Parent(s) or legal guardians have voluntarily signed and dated required participation forms, such as the ICF approved by an IRB.
Exclusion criteria
* An infant from a multiple birth, such as twin, triplet, or the like. * Personal or immediate family history of cow-milk protein allergy or intolerance. * Currently on any medication to treat growth failure or that may significantly impact growth. * Evidence of any anatomic and/or physiologic condition that would interfere with normal growth, development, or feeding, such as genetic, neurological, gastrointestinal, cardiac, pulmonary, hepatic, or renal. * A maternal history with known adverse effects on the fetus and/or the newborn infant, such as positive HIV, insulin-dependent diabetes, opioid exposure during pregnancy. * Enrolled in another clinical trial involving a drug, nutrition supplement, device, or intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight. | Study Day 1 to Study Day 112 | Weight. Weight gain velocity. g and g/day |
| Head circumference. | Study Day 1 to Study Day 112 | Head circumference. Head circumference gain velocity. cm and cm/day |
| Anthropometry Z-scores. | Study Day 1 to Study Day 112 | Weight for age Z-score. Length for age Z-score. Weight for length Z-score. Head circumference for age Z-score. |
| Formula intake. | Study Day 1 to Study Day 112 | Volume of formula consumed. ml/day |
| Length. | Study Day 1 to Study Day 112 | Length. Length gain velocity. cm and cm/day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal characteristic. | Study Day 1 to Study Day 112 | Stool consistency. Stools/day. Regurgitation. Gas. |
| Formula tolerance. | Study Day 1 to Study Day 112 | Frequency of adverse events. Fussiness. Inconsolable crying. |
Countries
United States
Outcome results
None listed