Neocate In Infants and Children With Complex Conditions (NICC)
11. februar 2020 oppdatert av: Nutricia Research
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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- GI Care for Kids
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- Prisma Health - Upstate
-
-
-
-
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London, Storbritannia
- Great Ormond Street Hospital
-
-
-
-
-
Munich, Tyskland
- Dr. von Haunersches LKinderspital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 10 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: single test product arm
use of Neocate Infant and Junior marketed products (product type depending on subject's age and condition)
|
use of Neocate Infant and Junior marketed products
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exploratory: Weight
Tidsramme: 0 weeks
|
Weight [in g/kg]
|
0 weeks
|
|
Exploratory: Weight
Tidsramme: 4 weeks
|
Weight [in g/kg]
|
4 weeks
|
|
Exploratory: Weight
Tidsramme: 16 weeks
|
Weight [in g/kg]
|
16 weeks
|
|
Exploratory: Weight
Tidsramme: 52 weeks
|
Weight [in g/kg]
|
52 weeks
|
|
Exploratory: Length
Tidsramme: 0 weeks
|
Length/height [in cm]
|
0 weeks
|
|
Exploratory: Length
Tidsramme: 4 weeks
|
Length/height [in cm]
|
4 weeks
|
|
Exploratory: Length
Tidsramme: 16 weeks
|
Length/height [in cm]
|
16 weeks
|
|
Exploratory: Length
Tidsramme: 52 weeks
|
Length/height [in cm]
|
52 weeks
|
|
Exploratory: head circumference
Tidsramme: 0 weeks
|
head circumference (for children <2 years of age) [in cm]
|
0 weeks
|
|
Exploratory: head circumference
Tidsramme: 4 weeks
|
head circumference (for children <2 years of age) [in cm]
|
4 weeks
|
|
Exploratory: head circumference
Tidsramme: 16 weeks
|
head circumference (for children <2 years of age) [in cm]
|
16 weeks
|
|
Exploratory: head circumference
Tidsramme: 52 weeks
|
head circumference (for children <2 years of age) [in cm]
|
52 weeks
|
|
Exploratory: Biochemical markers of nutritional status
Tidsramme: 0 weeks
|
Macronutrient, micronutrient and mineral levels in blood [in a.o.
mmol/L]
|
0 weeks
|
|
Exploratory: Biochemical markers of nutritional status
Tidsramme: 4 weeks
|
Macronutrient, micronutrient and mineral levels in blood [in a.o.
mmol/L]
|
4 weeks
|
|
Exploratory: Biochemical markers of nutritional status
Tidsramme: 16 weeks
|
Macronutrient, micronutrient and mineral levels in blood [in a.o.
mmol/L]
|
16 weeks
|
|
Exploratory: Biochemical markers of nutritional status
Tidsramme: 52 weeks
|
Macronutrient, micronutrient and mineral levels in blood [in a.o.
mmol/L]
|
52 weeks
|
|
Exploratory: Gastrointestinal tolerance
Tidsramme: 0 weeks
|
GastrointestinaI symptoms [none/mild/moderate/severe]
|
0 weeks
|
|
Exploratory: Gastrointestinal tolerance
Tidsramme: 4 weeks
|
GastrointestinaI symptoms [none/mild/moderate/severe]
|
4 weeks
|
|
Exploratory: Gastrointestinal tolerance
Tidsramme: 16 weeks
|
GastrointestinaI symptoms [none/mild/moderate/severe]
|
16 weeks
|
|
Exploratory: Gastrointestinal tolerance
Tidsramme: 52 weeks
|
GastrointestinaI symptoms [none/mild/moderate/severe]
|
52 weeks
|
|
Exploratory: Stool frequency
Tidsramme: 0 weeks
|
number of stools per day
|
0 weeks
|
|
Exploratory: Stool frequency
Tidsramme: 4 weeks
|
number of stools per day
|
4 weeks
|
|
Exploratory: Stool frequency
Tidsramme: 16 weeks
|
number of stools per day
|
16 weeks
|
|
Exploratory: Stool frequency
Tidsramme: 52 weeks
|
number of stools per day
|
52 weeks
|
|
Exploratory: Stool consistency
Tidsramme: 0 weeks
|
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
Tidsramme: 4 weeks
|
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
Tidsramme: 16 weeks
|
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
Tidsramme: 52 weeks
|
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
Tidsramme: 0 weeks
|
calculated energy, protein and micronutrient levels from parent diary [in a.o.
mg/d]
|
0 weeks
|
|
Exploratory: Nutrient intake
Tidsramme: 4 weeks
|
calculated energy, protein and micronutrient levels from parent diary [in a.o.
mg/d]
|
4 weeks
|
|
Exploratory: Nutrient intake
Tidsramme: 16 weeks
|
calculated energy, protein and micronutrient levels from parent diary [in a.o.
mg/d]
|
16 weeks
|
|
Exploratory: Nutrient intake
Tidsramme: 52 weeks
|
calculated energy, protein and micronutrient levels from parent diary [in a.o.
mg/d]
|
52 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. mars 2020
Primær fullføring (Forventet)
1. juli 2021
Studiet fullført (Forventet)
1. mars 2022
Datoer for studieregistrering
Først innsendt
28. januar 2020
Først innsendt som oppfylte QC-kriteriene
11. februar 2020
Først lagt ut (Faktiske)
12. februar 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. februar 2020
Sist bekreftet
1. februar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MPR18TA23134
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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