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Infant Formula and Toddler Drink Feeding Intervention

NCT04495738 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-05-14

No results posted yet for this study

Summary

The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.

Conditions

  • Respiratory Infections in Children

Interventions

OTHER

Control Infant Formula

Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age

OTHER

Control Toddler Drink

16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age

OTHER

Experimental Infant Formula

Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age

OTHER

Experimental Toddler Drink

16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age

OTHER

Supplemental Formula for HM Group

Ad libitum formula given up to 12 months of age if HM is supplemented

OTHER

Toddler Drink for HM group

16 fl oz per day if weaned from HM feedings

Sponsors & Collaborators

  • Abbott Nutrition

    lead INDUSTRY

Principal Investigators

  • Bridget Barrett Reis, PhD, RD · Abbott Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2021-04-12
Completion
2021-04-12

Countries

  • United States

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 NCT04495738 on ClinicalTrials.gov