NCT04265729

Neocate In Infants and Children With Complex Conditions

An Open-label, Explorative, Post Launch Study of Neocate Amino Acid-based Feeds to Evaluate Nutritional Status and Gastrointestinal Tolerance in Infants and Children With Complex Conditions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

Infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth. Due to the complex condition, standard nutrition is often not tolerated and causes gastrointestinal symptoms. Formulas in which protein is replaced by its smallest elements, amino acids are easier for the body to digest and absorb. These formulas might be tolerated better and reduce gastrointestinal symptoms in infants and young children with complex conditions. The objectives of the present, exploratory study are to gain clinical evidence related to the nutritional status and gastrointestinal tolerance in infants and young children with complex conditions receiving Neocate as their primary source of nutrition. Additional objectives are to describe the nutritional and pharmacological management of these infants and young children. Study duration for each participant will be 52 weeks at maximum.

Conditions

• Complex Conditions, Including Impairment of the GI Tract

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Neocate Infant and Junior marketed products	use of Neocate Infant and Junior marketed products

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-07-01
• Completion: 2022-03-01
• First posted: 2020-02-12
• Last updated: 2020-02-12

Locations

4 sites across 3 countries: United States, Germany, United Kingdom