New Infant Formula + Toddler Drink for Growth Development

Recruiting at 48 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

607 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new baby formula and toddler drink to see how they affect the growth and development of infants by providing essential nutrients.

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.

What data supports the effectiveness of this treatment for growth development in infants and toddlers?

The study on preterm infants showed that formulas, including those supplemented with human milk fortifiers, supported growth rates similar to in utero growth without stressing the infants' metabolic systems. This suggests that specialized formulas can aid in growth development. ^{1 2 3 4 5}

Is the new infant formula and toddler drink safe for human use?

A study on a cow's milk-based formula used in infants showed it was a valuable alternative to existing formulas, with growth rates comparable to reference values, suggesting it is generally safe. However, no specific safety data for the new infant formula and toddler drink is available in the provided research. ^{5 6 7 8 9}

How does the New Infant Formula + Toddler Drink treatment differ from other treatments for growth development in infants?

The New Infant Formula + Toddler Drink treatment is unique because it combines both infant and toddler formulas, potentially offering a more comprehensive approach to support growth and development across different early life stages. This treatment may also include human milk supplements, which could provide additional nutritional benefits compared to standard formulas. ^{1 2 3 10 11}

Research Team

Elizabeth Reverri, PhD, MS,

Principal Investigator

Abbott Nutrition

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Enhanced growth of preterm infants fed a new powdered human milk fortifier: A randomized, controlled trial. [2019]

2. Singapore pubmed.ncbi.nlm.nih.gov

Clinical experience with preterm formulas in very low birthweight infants. [2006]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Interventions to Manage Difficulties with Breastfeeding for Mothers of Infants under Six Months with Growth Faltering: A Systematic Review Update. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The role of infant appetite in extended formula feeding. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Toddler milk: a scoping review of research on consumption, perceptions, and marketing practices. [2023]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Testing of a liquid, ready-to-use, breast milk substitute in the county of Funen]. [2008]

7. United States pubmed.ncbi.nlm.nih.gov

The Design and Mechanics of an Accessible Human Milk Research Biorepository. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Infant formula and toddler milk marketing and caregiver's provision to young children. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

It's all formula to me: women's understandings of toddler milk ads. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[Effect of different feeding initiation formulas on very low birth weight infants]. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Promoting growth for preterm infants following hospital discharge. [2012]