Clinical trial NCT04265729: Neocate In Infants and Children With Complex Conditions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complex Conditions, Including Impairment of the GI Tract
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 40
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Exploratory: Weight
timeFrame: 0 weeks
measure: Exploratory: Weight
timeFrame: 4 weeks
measure: Exploratory: Weight
timeFrame: 16 weeks
measure: Exploratory: Weight
timeFrame: 52 weeks
measure: Exploratory: Length
timeFrame: 0 weeks
measure: Exploratory: Length
timeFrame: 4 weeks
measure: Exploratory: Length
timeFrame: 16 weeks
measure: Exploratory: Length
timeFrame: 52 weeks
measure: Exploratory: head circumference
timeFrame: 0 weeks
measure: Exploratory: head circumference
timeFrame: 4 weeks
measure: Exploratory: head circumference
timeFrame: 16 weeks
measure: Exploratory: head circumference
timeFrame: 52 weeks
measure: Exploratory: Biochemical markers of nutritional status
timeFrame: 0 weeks
measure: Exploratory: Biochemical markers of nutritional status
timeFrame: 4 weeks
measure: Exploratory: Biochemical markers of nutritional status
timeFrame: 16 weeks
measure: Exploratory: Biochemical markers of nutritional status
timeFrame: 52 weeks
measure: Exploratory: Gastrointestinal tolerance
timeFrame: 0 weeks
measure: Exploratory: Gastrointestinal tolerance
timeFrame: 4 weeks
measure: Exploratory: Gastrointestinal tolerance
timeFrame: 16 weeks
measure: Exploratory: Gastrointestinal tolerance
timeFrame: 52 weeks
measure: Exploratory: Stool frequency
timeFrame: 0 weeks
measure: Exploratory: Stool frequency
timeFrame: 4 weeks
measure: Exploratory: Stool frequency
timeFrame: 16 weeks
measure: Exploratory: Stool frequency
timeFrame: 52 weeks
measure: Exploratory: Stool consistency
timeFrame: 0 weeks
measure: Exploratory: Stool consistency
timeFrame: 4 weeks
measure: Exploratory: Stool consistency
timeFrame: 16 weeks
measure: Exploratory: Stool consistency
timeFrame: 52 weeks
measure: Exploratory: Nutrient intake
timeFrame: 0 weeks
measure: Exploratory: Nutrient intake
timeFrame: 4 weeks
measure: Exploratory: Nutrient intake
timeFrame: 16 weeks
measure: Exploratory: Nutrient intake
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: GI Care for Kids
state: Georgia
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Munich
country: Germany
facility: Dr. von Haunersches LKinderspital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
References: