Neocate In Infants and Children With Complex Conditions

Not Applicable

• Conditions: Complex Conditions, Including Impairment of the GI Tract
• Interventions: Dietary Supplement: Neocate Infant and Junior marketed products

• Registration Number: NCT04265729
• Lead Sponsor: Nutricia Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-28
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Study First Posted: 2020-02-12
• Last Update Posted: 2020-02-12
• Study Start: 2020-03
• Primary Completion: 2021-07
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Infants and young children aged from 0 up to and including 10 years of age.
• Severe impairment of at least 1 organ system
• Impairment of the gastrointestinal tract, i.e. gastrointestinal disease, congenital abnormality, surgical resection, or gastrointestinal dysfunction (including symptoms of gastrointestinal dysmotility or malabsorption).
• Receiving at least 75% of their energy intake from Neocate (Neocate Infant or Junior powdered (marketed) product) at the time of study entry (V1).
• Expected to receive at least 75% of their energy intake from the study product for at least 4 weeks from study entry (V1).
• Written informed consent provided by parents/guardians and assent by the child, if applicable, according to local law.

Exclusion Criteria

• Infants born with a gestational age <37 weeks that are <40 weeks corrected age at the time of study entry (V1).
• Infants or children with endoscopically confirmed eosinophilic oesophagitis and prescribed an amino acid-based formula only for the management of the eosinophilic oesophagitis.
• Infants or children with a medical diagnosis that includes only (suspected) cow's milk allergy and/or multiple food allergy.
• Infants or children with renal dysfunction, e.g. acute or chronic kidney failure or kidney cancer.
• Infants or children with thyroid disorder or parathyroid disorder.
• Expected to receive parenteral nutrition during intervention from study entry (V1).
• Participation in any other studies involving investigational or marketed products concomitantly or within 1 month prior to study entry (V1).
• Investigator's uncertainty about the willingness or ability of the parents/guardians to comply with the protocol requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single test product arm	Neocate Infant and Junior marketed products	use of Neocate Infant and Junior marketed products (product type depending on subject's age and condition)

Primary Outcome Measures

Name	Time	Method
Exploratory: Biochemical markers of nutritional status	52 weeks	Macronutrient, micronutrient and mineral levels in blood \[in a.o. mmol/L\]
Exploratory: Stool frequency	52 weeks	number of stools per day
Exploratory: Stool consistency	52 weeks	parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Exploratory: Nutrient intake	52 weeks	calculated energy, protein and micronutrient levels from parent diary \[in a.o. mg/d\]
Exploratory: head circumference	52 weeks	head circumference (for children \<2 years of age) \[in cm\]
Exploratory: Gastrointestinal tolerance	52 weeks	GastrointestinaI symptoms \[none/mild/moderate/severe\]
Exploratory: Weight	52 weeks	Weight \[in g/kg\]
Exploratory: Length	52 weeks	Length/height \[in cm\]

Trial Locations

Locations (4)

GI Care for Kids; 🇺🇸 Atlanta, Georgia, United States

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom

Dr. von Haunersches LKinderspital; 🇩🇪 Munich, Germany

Prisma Health - Upstate; 🇺🇸 Greenville, South Carolina, United States