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The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants

NCT04508257 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2020-08-18

No results posted yet for this study

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.

Conditions

  • Child Development

Interventions

DIETARY_SUPPLEMENT

Oral feeding of Investigational Formula (Stage 1&2)

Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.

DIETARY_SUPPLEMENT

Oral feeding of Control formula (Stage 1&2)

Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.

DIETARY_SUPPLEMENT

Breast feeding

Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.

Sponsors & Collaborators

  • Heilongjiang Feihe Dairy Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Gong Zhang, M.D., Ph.D. · Anhui Medical University Affiliated Children's Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508257 on ClinicalTrials.gov