Neocate In Infants and Children With Complex Conditions (NICC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Complex Conditions, Including Impairment of the GI Tract
• Intervention / Treatment: Dietary supplement: Neocate Infant and Junior marketed products

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danone Nutricia Research; Phone Number: +31 30 295000; Email: register.clinicalresearchnutricia@danone.com

Study Locations

• Germany
  • Munich, Germany
    • Dr. von Haunersches LKinderspital
    • Contact: Prof. Dr. S. Koletzko
• United Kingdom
  • London, United Kingdom
    • Great Ormond Street Hospital
    • Contact: Dr. O. Borrelli
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GI Care for Kids
      • Contact: Dr. B. Gold
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health - Upstate
      • Contact: Dr. M. Dougherty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single test product arm; use of Neocate Infant and Junior marketed products (product type depending on subject's age and condition)	Dietary supplement: Neocate Infant and Junior marketed products; use of Neocate Infant and Junior marketed products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Weight	Weight [in g/kg]	0 weeks
Exploratory: Weight	Weight [in g/kg]	4 weeks
Exploratory: Weight	Weight [in g/kg]	16 weeks
Exploratory: Weight	Weight [in g/kg]	52 weeks
Exploratory: Length	Length/height [in cm]	0 weeks
Exploratory: Length	Length/height [in cm]	4 weeks
Exploratory: Length	Length/height [in cm]	16 weeks
Exploratory: Length	Length/height [in cm]	52 weeks
Exploratory: head circumference	head circumference (for children <2 years of age) [in cm]	0 weeks
Exploratory: head circumference	head circumference (for children <2 years of age) [in cm]	4 weeks
Exploratory: head circumference	head circumference (for children <2 years of age) [in cm]	16 weeks
Exploratory: head circumference	head circumference (for children <2 years of age) [in cm]	52 weeks
Exploratory: Biochemical markers of nutritional status	Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]	0 weeks
Exploratory: Biochemical markers of nutritional status	Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]	4 weeks
Exploratory: Biochemical markers of nutritional status	Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]	16 weeks
Exploratory: Biochemical markers of nutritional status	Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]	52 weeks
Exploratory: Gastrointestinal tolerance	GastrointestinaI symptoms [none/mild/moderate/severe]	0 weeks
Exploratory: Gastrointestinal tolerance	GastrointestinaI symptoms [none/mild/moderate/severe]	4 weeks
Exploratory: Gastrointestinal tolerance	GastrointestinaI symptoms [none/mild/moderate/severe]	16 weeks
Exploratory: Gastrointestinal tolerance	GastrointestinaI symptoms [none/mild/moderate/severe]	52 weeks
Exploratory: Stool frequency	number of stools per day	0 weeks
Exploratory: Stool frequency	number of stools per day	4 weeks
Exploratory: Stool frequency	number of stools per day	16 weeks
Exploratory: Stool frequency	number of stools per day	52 weeks
Exploratory: Stool consistency	parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery	0 weeks
Exploratory: Stool consistency	parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery	4 weeks
Exploratory: Stool consistency	parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery	16 weeks
Exploratory: Stool consistency	parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery	52 weeks
Exploratory: Nutrient intake	calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]	0 weeks
Exploratory: Nutrient intake	calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]	4 weeks
Exploratory: Nutrient intake	calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]	16 weeks
Exploratory: Nutrient intake	calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]	52 weeks

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: MPR18TA23134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No