Clinical trial NCT04671576: Growth and Safety Clinical Trial on a New Infant Formula.
Official title: Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Growth
Keywords: infant formula
cow milk
growth
Lead sponsor: Nara Organics
Sponsor class: INDUSTRY
Collaborators: name: Paidion Research, Inc.
First posted: 2020-12-17
Enrollment: 176
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Formula intake.
timeFrame: Study Day 1 to Study Day 112
measure: Weight.
timeFrame: Study Day 1 to Study Day 112
measure: Length.
timeFrame: Study Day 1 to Study Day 112
measure: Head circumference.
timeFrame: Study Day 1 to Study Day 112
measure: Anthropometry Z-scores.
timeFrame: Study Day 1 to Study Day 112
Secondary outcomes:
measure: Formula tolerance.
timeFrame: Study Day 1 to Study Day 112
measure: Gastrointestinal characteristic.
timeFrame: Study Day 1 to Study Day 112
Other outcomes:
Locations:
city: Cary
country: United States
facility: TeleResearch Hub
state: North Carolina
Study officials:
affiliation: Paidion Research, Inc.
name: Amanda Fingarson, DO
role: STUDY_DIRECTOR
affiliation: Telehub Research
name: Tiffany Petty, MD
role: PRINCIPAL_INVESTIGATOR
References: