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New Infant Formula + Toddler Drink for Growth Development
Study Summary
This trial will test a new infant formula and toddler drink to see if it leads to better growth and development outcomes in infants through 24 months of age.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My baby has been and will be exclusively breastfed until 6 months old.My baby has been and will be exclusively breastfed until 6 months old.I have taken antibiotics before joining this study.I was born full-term, between 37 and 42 weeks.I was born weighing at least 5 lbs. 8 oz.I am taking medications or remedies that could affect my stomach's tolerance.I plan to feed my infant only the study product until they are 6 months old, and as their only milk until 12 months.I agree to use the study's formula and toddler drink for my child if I decide to supplement or wean.I plan to give my child the specified toddler drink as their main milk from 12 to 24 months.I will not give my child any vitamins or minerals except vitamin D if a doctor says so.I will not give my baby solid foods or juices until they are 6 months old, unless a doctor advises otherwise.I plan to give my child the specified toddler drink as their main milk from 12 to 24 months.I will not give my baby solid foods or juices until they are 6 months old, unless a doctor advises otherwise.I will not give my child any vitamins or minerals except vitamin D if recommended.
- Group 1: Control Feeding Group
- Group 2: Experimental Feeding Group
- Group 3: Human Milk Reference Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any opportunities for enrollment in this research experiment?
"According to the information available on clinicialtrials.gov, this trial is actively enrolling eligible participants. It was published in July of 2021 and most recently updated September 20th 2022."
To what extent has this research study been implemented in the United States?
"Holston Medical Group 3064 in Kingsport, Tennessee, The Children's Clinic of Jonesboro, P.A. in Jonesboro, Arkansas and Advantage Clincial Trials in Bronx, New york are three medical centres amongst 37 other locations where patients can enrol for this study."
How many participants are currently eligible for enrollment in this trial?
"The clinical trial necessitates the recruitment of 510 patients that meet a specified set of inclusion criteria. Eligible participants can sign up for the research at medical centres such as Holston Medical Group 3064 in Kingsport, Tennessee and The Children's Clinic of Jonesboro, P.A. in Jonesboro, Arkansas."
Are minors permitted to participate in this investigation?
"This medical trial is open to individuals aged 0 Days to 14 Days. There are 6 studies for minors and 2 studies specially designed for participants over 65 years of age."
Are my qualifications sufficient to participate in this scientific experiment?
"This clinical trial seeks 510 neonates aged 0 to 14 days with growth variants. In order for an infant to qualify, their parents must meet the following conditions: demonstrate that they are in good health; confirm intention to feed toddler drink as primary milk beverage until 24 months of age; pledge not to give vitamin/mineral supplements (except Vitamin d if instructed); promise not use solid foods or juices till 6 months unless recommended by HCP; voluntarily sign ICF and HIPAA authorization before study begins; exclusively breastfeed through 6 months if human milk is chosen; supplement or wean using given formula & drink and be a singleton from full"
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