Status:
COMPLETED
Growth and Safety Clinical Trial on a New Infant Formula.
Lead Sponsor:
Nara Organics
Collaborating Sponsors:
Paidion Research, Inc.
Conditions:
Healthy Growth
Eligibility:
All Genders
1-14 years
Phase:
NA
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 accor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04671576
Start Date
February 12 2021
End Date
August 12 2022
Last Update
September 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
TeleResearch Hub
Cary, North Carolina, United States, 27519