Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-25 @ 4:14 PM
Study NCT ID:
NCT04508257
Status:
UNKNOWN
Last Update Posted:
2020-08-18
First Post:
2020-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants
Sponsor:
Heilongjiang Feihe Dairy Co. Ltd.
Organization:
Study Overview
Official Title:
Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Nutritive Effects of Two Staged Infant Formulas on Growth and Cognitive Outcomes in Healthy Term Infants
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the nutritive effects of two staged study formulas on growth and cognitive outcomes. Approximately 450 participants will be enrolled with the expectation of having 105 participants per group (315 for three groups: control group, investigational group, and breastfeeding reference group ) complete Study Visit 6 at 365 days of age ± 7 days (allowing for a 30% drop-out rate). Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age. The study period will include feeding up to 365 days of age and cognitive testing up to 365 days of age. Stool samples will be collected from a subset of participants at enrollment and at 120 days of age for fecal microbiome analysis.
Detailed Description:
Primary Objective
* Compare measures of normal, healthy mental development at 365 days of age among infants receiving an investigational formula, infants receiving the control and breastfed group.
Secondary Objectives
To compare between the two study groups:
* Measures of mental development up to 365 days of age
* Rate of body weight, length and head circumference gain
* Achieved weight, length and head circumference
* Stool characteristics, tolerance and formula acceptance
* Fecal microbiome analysis
* Antibiotic treatment
* Medically-confirmed adverse
* Compare measures of normal, healthy mental development at 365 days of age among infants receiving an investigational formula, infants receiving the control and breastfed group.
Secondary Objectives
To compare between the two study groups:
* Measures of mental development up to 365 days of age
* Rate of body weight, length and head circumference gain
* Achieved weight, length and head circumference
* Stool characteristics, tolerance and formula acceptance
* Fecal microbiome analysis
* Antibiotic treatment
* Medically-confirmed adverse
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: