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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
use of Neocate Infant and Junior marketed products
GI Care for Kids
Atlanta, Georgia, United States
Prisma Health - Upstate
Greenville, South Carolina, United States
Dr. von Haunersches LKinderspital
Munich, Germany
Great Ormond Street Hospital
London, United Kingdom
Exploratory: Weight
Weight \[in g/kg\]
Time frame: 0 weeks
Exploratory: Weight
Weight \[in g/kg\]
Time frame: 4 weeks
Exploratory: Weight
Weight \[in g/kg\]
Time frame: 16 weeks
Exploratory: Weight
Weight \[in g/kg\]
Time frame: 52 weeks
Exploratory: Length
Length/height \[in cm\]
Time frame: 0 weeks
Exploratory: Length
Length/height \[in cm\]
Time frame: 4 weeks
Exploratory: Length
Length/height \[in cm\]
Time frame: 16 weeks
Exploratory: Length
Length/height \[in cm\]
Time frame: 52 weeks
Exploratory: head circumference
head circumference (for children \<2 years of age) \[in cm\]
Time frame: 0 weeks
Exploratory: head circumference
head circumference (for children \<2 years of age) \[in cm\]
Time frame: 4 weeks
Exploratory: head circumference
head circumference (for children \<2 years of age) \[in cm\]
Time frame: 16 weeks
Exploratory: head circumference
head circumference (for children \<2 years of age) \[in cm\]
Time frame: 52 weeks
Exploratory: Biochemical markers of nutritional status
Macronutrient, micronutrient and mineral levels in blood \[in a.o. mmol/L\]
Time frame: 0 weeks
Exploratory: Biochemical markers of nutritional status
Macronutrient, micronutrient and mineral levels in blood \[in a.o. mmol/L\]
Time frame: 4 weeks
Exploratory: Biochemical markers of nutritional status
Macronutrient, micronutrient and mineral levels in blood \[in a.o. mmol/L\]
Time frame: 16 weeks
Exploratory: Biochemical markers of nutritional status
Macronutrient, micronutrient and mineral levels in blood \[in a.o. mmol/L\]
Time frame: 52 weeks
Exploratory: Gastrointestinal tolerance
GastrointestinaI symptoms \[none/mild/moderate/severe\]
Time frame: 0 weeks
Exploratory: Gastrointestinal tolerance
GastrointestinaI symptoms \[none/mild/moderate/severe\]
Time frame: 4 weeks
Exploratory: Gastrointestinal tolerance
GastrointestinaI symptoms \[none/mild/moderate/severe\]
Time frame: 16 weeks
Exploratory: Gastrointestinal tolerance
GastrointestinaI symptoms \[none/mild/moderate/severe\]
Time frame: 52 weeks
Exploratory: Stool frequency
number of stools per day
Time frame: 0 weeks
Exploratory: Stool frequency
number of stools per day
Time frame: 4 weeks
Exploratory: Stool frequency
number of stools per day
Time frame: 16 weeks
Exploratory: Stool frequency
number of stools per day
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 52 weeks
Exploratory: Nutrient intake
calculated energy, protein and micronutrient levels from parent diary \[in a.o. mg/d\]
Time frame: 0 weeks
Exploratory: Nutrient intake
calculated energy, protein and micronutrient levels from parent diary \[in a.o. mg/d\]
Time frame: 4 weeks
Exploratory: Nutrient intake
calculated energy, protein and micronutrient levels from parent diary \[in a.o. mg/d\]
Time frame: 16 weeks
Exploratory: Nutrient intake
calculated energy, protein and micronutrient levels from parent diary \[in a.o. mg/d\]
Time frame: 52 weeks
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