New Infant Formula + Toddler Drink for Growth Development

No longer recruiting at 49 trial locations

Overseen By Kristen DeLuca, MS, RDN, LDN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Nutrition

Must not be taking: Antibiotics, Probiotics, Herbal remedies, others

Disqualifiers: Substance abuse, Positive drug screen, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively a new infant formula and toddler drink support growth and development in children up to 24 months old. Researchers will compare various feeding options, including experimental formulas with added nutrients, standard formulas, and human milk. Ideal candidates are healthy, full-term infants with a birth weight of approximately 5 lbs. 8 oz. or more, whose parents intend to follow the study's feeding guidelines through the toddler years. As an unphased trial, this study provides a unique opportunity for parents to contribute to significant research on infant nutrition.

Will I have to stop taking my current medications?

Yes, participants must stop taking medications, home remedies, herbal preparations, prebiotics, probiotics, or rehydration fluids that might affect gastrointestinal tolerance. If the participant is currently on such treatments, they may need to discontinue them before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that infant formulas similar to human milk are generally safe and nutritious. These formulas are designed to closely match babies' nutritional needs, indicating they are well-tolerated. However, some specialized formulas may contain more sugar, raising concerns about obesity or tooth decay if consumed in large amounts.

Manufacturers often make toddler drinks from powdered milk, sweeteners, and oils. While popular, careful use is important because they are processed. Always check the nutrient balance in these drinks to ensure they support a child's growth and health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they introduce milk-based products enhanced with oligosaccharides, which are special carbohydrates that may promote healthy gut bacteria. Unlike standard infant formulas and toddler drinks, these experimental versions aim to more closely mimic the beneficial components found in human milk. This innovation could potentially support better growth and development in infants and toddlers by boosting their digestive and immune health.

What evidence suggests that this trial's treatments could be effective for growth development?

Research shows that the new experimental infant formula and toddler drink, which participants in this trial may receive, contains oligosaccharides, a type of carbohydrate that may support growth and development in young children. Studies have found that formulas with added carbohydrates can improve gut health, which is important for overall growth. While the World Health Organization states that toddler milk isn't necessary for optimal growth, some studies suggest certain formulas can be beneficial. Previous research indicates that children who consume cow-milk-based formulas often grow faster than those who don't. These findings suggest the new formula could effectively promote healthy growth and development in infants and toddlers. ^{1 4 6 7 8}

Who Is on the Research Team?

Elizabeth Reverri, PhD, MS, RD

Principal Investigator

Abbott Nutrition

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My baby has been and will be exclusively breastfed until 6 months old.

Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study

I was born full-term, between 37 and 42 weeks.

Exclusion Criteria

Suspected maternal substance abuse including alcohol

Participant is in another study that has not been approved as a concomitant study by AN

An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants are fed a new infant formula and toddler drink, with growth and development outcomes evaluated

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control Infant Formula
• Control Toddler Drink
• Experimental Infant Formula
• Experimental Toddler Drink
• Human Milk Supplemental Formula
• Human Milk Toddler Drink

Trial Overview 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.

How Is the Trial Designed?

Group I: Human Milk Reference Group Experimental Treatment 3 Interventions

Human Milk

Group II: Experimental Feeding Group Experimental Treatment 2 Interventions

Milk based product with oligosaccharides

Group III: Control Feeding Group Active Control 2 Interventions

Milk based product

Who Is Running the Clinical Trial?

Abbott Nutrition

Lead Sponsor

Trials

173

Recruited

33,700+

Robert B. Ford

Abbott Nutrition

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Melissa Brotz

Abbott Nutrition

Chief Marketing Officer

Bachelor's degree in Journalism from Northwestern University

Published Research Related to This Trial

In a study of 144 preterm infants, those receiving a new powdered human milk fortifier (SF) showed significantly greater weight gain and length growth compared to those receiving a commercial fortifier (CF), with weight gain differences of 2.6 g/kg/day in the intent-to-treat analysis.

The new fortifier (SF) was well-tolerated and led to faster growth milestones, with infants reaching 1800 g weight at an earlier time (SDAY 18) compared to those on the CF (SDAY 25), indicating its potential as a superior nutritional supplement for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced growth of preterm infants fed a new powdered human milk fortifier: A randomized, controlled trial. Reis, BB., Hall, RT., Schanler, RJ., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04495738?ageRange=0M_1M&cond=Infections&aggFilters=studyType:int&distance=50&intr=Investigational%20Agent&rank=3

Infant Formula and Toddler Drink Feeding Intervention The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10859688/

Toddler milk: a scoping review of research on consumption ... For these reasons, the World Health Organization considers toddler milk unnecessary for optimum child growth and development. Despite the growth ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04957992

NCT04957992 | BIG Study (Brain, Immune, and Gut Health ... The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12525715/

Effects of Infant Formula Type on Early Childhood Growth ... Objective: This study examines the effects of non-standard (lactose-reduced, hydrolyzed), cow-milk-based infant formulas on early childhood ...

5. nutrition.bmj.com nutrition.bmj.com/content/6/Suppl_2/s12

Plant based drinks in the diets of infants and young children According to recent studies, children who do not drink CM grow slower than those who do. There is relatively little information about the role ...

6. scitechdaily.com scitechdaily.com/change-your-kids-diet-too-many-children-drink-specialized-baby-formula/

Too Many Children Drink Specialized Baby Formula The results are troubling since specialized formula has increased sugar content, which could promote obesity and tooth decay in young children.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10320619/

A comprehensive review on infant formula: nutritional and ... In this review, we have focused on the formulation and manufacturing of safe and nutritious infant formula equivalent to human milk or aligning with the infant ...

8. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-020-02087-9

Effect of feeding mode on infant growth and cognitive function The objective of the current study is to determine how the addition of bMFGM in infant formula and consumption in early infancy affects physical growth and ...