Growth and Safety Clinical Trial on a New Infant Formula.

Not Applicable

Completed

• Conditions: Healthy Growth
• Interventions: Other: Control Infant Formula; Other: Organic Infant Formula

• Registration Number: NCT04671576
• Lead Sponsor: Nara Organics

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

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-17
• Study Start: 2021-02-12
• Status Verified: 2022-08
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Formula	Control Infant Formula	A standard, milk-based, infant formula.
Investigational Formula	Organic Infant Formula	An organic milk-based infant formula.

Primary Outcome Measures

Name	Time	Method
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.
Weight.	Study Day 1 to Study Day 112	Weight. Weight gain velocity. g and g/day

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

TeleResearch Hub; 🇺🇸 Cary, North Carolina, United States