← Back to Search

Control Formula

New Infant Formula + Toddler Drink for Growth Development

N/A
Waitlist Available
Research Sponsored by Abbott Nutrition
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parent(s) confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life
Parent(s) confirm their intention not to administer vitamin or mineral supplements (except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months of age to 24 months of age
Awards & highlights

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.

Who is the study for?
Healthy infants, single birth, full-term (37-42 weeks), with a birth weight of ≥2490g. Parents must feed only the study product for the first 6 months and as primary milk beverage up to 24 months. No solid foods or juices until recommended by healthcare professional. Excludes those with adverse medical history affecting growth/development, drug exposure, in another study not approved by AN, treated with antibiotics or medications that may affect growth prior to enrollment.Check my eligibility
What is being tested?
The trial is testing new infant formula and toddler drinks against controls and human milk options from birth to 24 months old. It aims to assess how these products impact infant growth and development over this period.See study design
What are the potential side effects?
Since this trial involves dietary products for infants rather than drugs, traditional side effects are not expected; however, tolerance such as gastrointestinal reactions will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I plan to feed my infant only the study product until they are 6 months old, and as their only milk until 12 months.
Select...
I will not give my child any vitamins or minerals except vitamin D if a doctor says so.
Select...
I will not give my baby solid foods or juices until they are 6 months old, unless a doctor advises otherwise.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months of age to 24 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months of age to 24 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Growth
Secondary outcome measures
Gastrointestinal Tolerance
Head Circumference
Incidence of infection morbidity between study groups
+5 more
Other outcome measures
Adverse Events
Bayley™-4 Scale of Infant & Toddler Development IV
Blood Collection
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Human Milk Reference GroupExperimental Treatment3 Interventions
Human Milk
Group II: Experimental Feeding GroupExperimental Treatment2 Interventions
Milk based product with oligosaccharides
Group III: Control Feeding GroupActive Control2 Interventions
Milk based product

Find a Location

Who is running the clinical trial?

Abbott NutritionLead Sponsor
166 Previous Clinical Trials
32,590 Total Patients Enrolled
3 Trials studying Growth
701 Patients Enrolled for Growth
Bridget Barrett Reis, PhD, RDStudy ChairAbbott Nutrition
2 Previous Clinical Trials
346 Total Patients Enrolled
1 Trials studying Growth
178 Patients Enrolled for Growth

Media Library

Control Infant Formula (Control Formula) Clinical Trial Eligibility Overview. Trial Name: NCT04957992 — N/A
Growth Research Study Groups: Control Feeding Group, Experimental Feeding Group, Human Milk Reference Group
Growth Clinical Trial 2023: Control Infant Formula Highlights & Side Effects. Trial Name: NCT04957992 — N/A
Control Infant Formula (Control Formula) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04957992 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Kissimmee Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
~203 spots leftby Jul 2025