What side effects are associated with this type of intervention?

Nutritional supplements, including infant formulas and toddler drinks, are generally considered safe and effective for promoting growth in children. Studies have shown that these interventions can lead to significant improvements in height and weight without serious adverse events. However, some potential side effects may include mild gastrointestinal issues such as bloating, gas, or constipation. It is important to monitor for any allergic reactions or intolerances to specific ingredients in the formulas. Overall, the safety profile of these nutritional interventions is favorable, with few reported side effects.

What prior FDA approvals exist?

The FDA has approved various nutritional interventions aimed at supporting growth in infants and children. One notable example is the energy- and protein-enriched formula (EPEF), which has been shown to improve weight gain in infants with poor growth due to various etiologies, including congenital heart disease and other organic causes. These formulas are designed to provide enhanced caloric and protein intake to support optimal growth and development, similar to the objectives of the new infant formula and toddler drink being studied for growth and development outcomes.

What other types of research exist?

Promising alternatives to New Infant Formula and Toddler Drink for nutritional support in growth patients include: 1) Specialized formulas enriched with long-chain polyunsaturated fatty acids (LCPUFAs) and prebiotics, which have been shown to support brain development and gut health. 2) Nutritional supplements such as recombinant human growth hormone (rhGH) for specific conditions like growth hormone deficiency. 3) Enteral nutrition therapies, particularly for children with conditions like Crohn's disease or cystic fibrosis, which can help maintain remission and improve growth outcomes. 4) Behavioral and nutritional interventions tailored to increase calorie and nutrient intake in children with specific growth challenges. These alternatives should be discussed with a healthcare provider to determine the best individualized approach.

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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

Must not have

Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months of age to 24 months of age

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have taken antibiotics before joining this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months of age to 24 months of age

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Growth

Secondary study objectives

Gastrointestinal Tolerance

Head Circumference

Incidence of infection morbidity between study groups

+5 more

Other study objectives

Adverse Events

Bayley™-4 Scale of Infant & Toddler Development IV

Blood Collection

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for growth, particularly in infants, often involve nutrient-enriched formulas and macronutrient supplementation. These treatments work by providing essential nutrients that support overall growth and development. Enhanced protein and calorie intake are critical for improving metabolic outcomes and reducing motor impairments. Early nutritional interventions are vital as they can lead to significant long-term benefits in physical and cognitive development, ensuring better health outcomes for growth patients.

Somatic growth in infants receiving prolonged caffeine therapy.Early diet in preterm babies and developmental status at 18 months.Does it matter how we feed premature babies?