Growing Up Formula vs Nutritional Supplements for Toddler Malnutrition

(KEEP Growing Trial)

Overseen By Clinical Research Coordinator

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: GERD medications

Disqualifiers: Tube feeding, Food allergies, Genetic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

41 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a special formula called Enfagrow helps picky-eating toddlers eat more solid food and grow better. It focuses on young children who struggle with eating and gaining weight.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. However, toddlers with certain health conditions requiring medications, like GERD, are excluded from the trial.

What data supports the effectiveness of the treatment Enfagrow® Neuropro Toddler Nutritional Drink and Pediasure® Grow & Gain Protein Shake for Kids in addressing toddler malnutrition?

Research shows that PediaSure, a similar nutritional supplement, is effective in promoting growth and maintaining nutritional status in children who need extra nutritional support. Studies have demonstrated weight gain and improved growth metrics in malnourished children using PediaSure, indicating its potential effectiveness in addressing toddler malnutrition. ^{1 2 3 4 5}

Is PediaSure safe for children?

PediaSure has been shown to be safe for children, as a study found it was well-tolerated and supported growth in chronically disabled children over a 12-week period. ^{3 4 6 7 8}

How does the treatment for toddler malnutrition differ from other treatments?

The treatment using Enfagrow® Neuropro Toddler Nutritional Drink and Pediasure® Grow & Gain Protein Shake is unique because it specifically targets toddler malnutrition with a focus on providing essential nutrients in a form that is easy for young children to consume and tolerate. Unlike other treatments that may require medical interventions or specialized feeding methods, these nutritional drinks are designed to be a convenient and palatable option for improving growth and nutritional status in toddlers. ^{1 3 6 8 9}

Research Team

Liliane Diab, MD

Principal Investigator

Children's Hospital Colorado

Eligibility Criteria

This trial is for toddlers aged 12-36 months with mild to moderate malnutrition, as indicated by specific growth measurements like weight-for-length or BMI z-scores. It's aimed at those who may not eat enough solid foods and need nutritional support.

Inclusion Criteria

My toddler is mildly or moderately malnourished according to health standards.

Exclusion Criteria

Toddlers currently on or with history of tube feeding or with chronic health conditions that influence eating, Toddlers born at less than 34 weeks gestation, Toddlers with gastroesophageal reflux disease (GERD) requiring medications or specific formula, Toddlers with suspected malabsorption or conditions that increase metabolic demands, Toddlers with diagnosed allergy to cow's milk, Families who do not speak English or Spanish in the home.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Growing Up Formula (GUF) or the Standard Nutritional Supplement (NS) to assess effects on growth and solid food intake

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enfagrow® Neuropro Toddler Nutritional Drink
• Pediasure® Grow & Gain Protein Shake for Kids

Trial Overview The study compares a growing-up formula (Enfagrow) with a common children's nutritional supplement (Pediasure). The goal is to see if Enfagrow can help these toddlers eat more solid food and improve their growth compared to Pediasure.

Participant Groups

Group I: Growing Up Formula (GUF) Experimental Treatment 1 Intervention

Group II: Standard Nutritional Supplement (NS) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Mead Johnson Nutrition

Industry Sponsor

Trials

80

Recruited

15,900+

Findings from Research

A study involving 14 chronically disabled children showed that PediaSure, a new pediatric enteral product, effectively met their nutritional needs over a 12-week period, leading to significant improvements in growth measurements such as weight and length.

The product was well-tolerated with excellent gastrointestinal acceptance, and there were no clinically significant adverse effects, indicating that PediaSure is both safe and effective for maintaining nutritional status in young children requiring specialized support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new pediatric enteral product in the young child. Ramstack, M., Listernick, R.[2017]

In a study of 31 severely malnourished children aged 1-5 years, using 'PediaSure' for 2 weeks resulted in a significant increase in caloric intake and an average weight gain of 7.5 gm/kg/day, indicating its efficacy in nutritional rehabilitation.

The use of 'PediaSure' was well-tolerated with no reported cases of diarrhea or significant chemical imbalances, suggesting it is a safe option for initial nutrition therapy in malnourished children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PediaSure in the treatment of severe malnutrition in Pakistani children. Akram, DS., Bharmal, FY., Hussain, T.[2008]

References

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

Energy- and protein-enriched formula improves weight gain in infants with malnutrition due to cardiac and noncardiac etiologies. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Expressed Breast Milk Analysis: Role of Individualized Protein Fortification to Avoid Protein Deficit After Preterm Birth and Improve Infant Outcomes. [2023]

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

Safety and efficacy of a new pediatric enteral product in the young child. [2017]

4. Pakistan pubmed.ncbi.nlm.nih.gov

PediaSure in the treatment of severe malnutrition in Pakistani children. [2008]

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

Dietary management of malnourished children with a new enteral feeding. [2013]

6. Bulgaria pubmed.ncbi.nlm.nih.gov

[The feeding of newborns with low birth weight with milk formula "Nenatal" and "Nutrilon-premium"]. [2006]

7. Canada pubmed.ncbi.nlm.nih.gov

Development, reliability, and validity testing of Toddler NutriSTEP: a nutrition risk screening questionnaire for children 18-35 months of age. [2022]

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

Pediatric experience with intradialytic parenteral nutrition and supplemental tube feeding. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cortical Visual Evoked Potentials and Growth in Infants Fed with Bioactive Compounds-Enriched Infant Formula: Results from COGNIS Randomized Clinical Trial. [2020]