- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01936246
Protein Supplementation in Infants With Brain Injury
To date, few studies have been done regarding nutrition supplementation in infants with brain injury. Therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies. The investigators will recruit 24 infants with brain injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon diagnosis, the investigators will obtain consent from the parents for participation in the study, then randomly assign the baby to one of two groups - an increased protein group and a control group. Both groups of infants will be monitored to ensure no adverse effects occur due to the supplementation.
Protein supplementation will continue for the first 12 months of age. Growth parameters, such as weight, length, and head circumference, will be measured while the infant is the NICU. Head circumference will be measured in the investigators outpatient clinic at three, six, and 12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes using the Bayley Scales of Infant Development. The investigators hypothesize that infants who receive the additional protein will demonstrate increased head growth and improved neurodevelopmental outcomes.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Infants admitted to the NICU at CCHMC
- Known or suspected brain injury
- Parental consent obtained
- At least 48 hours of age at the time of randomization
Exclusion Criteria:
- Congenital or posthemorrhagic hydrocephalus
- Major congenital brain malformations
- Congenital gastrointestinal malformations or Bell Stage III NEC
- Inborn errors of metabolism
- Chromosomal abnormalities
- Significant cardiac disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Increased protein
Full term infants will be on 4 g/kg/day of protein.
Preterm infants will be on 4.5 g/kg/day of protein until term corrected age.
Beneprotein powder will be used; if this is not tolerated, Complete Amino Acids will be used.
Max protein will be 30 g/day.
Increased protein will be given until 12 months corrected age.
|
Andre navne:
|
Ingen indgriben: Standard diet
Infants will be given a usual diet.
If infants in this arm have poor growth, protein or caloric supplementation may be given per the discretion of the clinical team.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Head circumference
Tidsramme: 12 months of age +/- 4 weeks
|
12 months of age +/- 4 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Neurodevelopmental outcome on Bayley Scales of Infant Development
Tidsramme: 18-22 months
|
18-22 months
|
Weight and length
Tidsramme: 3, 6, 12 months of age
|
3, 6, 12 months of age
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood urea nitrogen
Tidsramme: 10 and 30 days post study initiation
|
10 and 30 days post study initiation
|
|
CO2 from renal panel
Tidsramme: 10 and 30 days post study initiation
|
To assess for metabolic acidosis
|
10 and 30 days post study initiation
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCHMCProtein
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Perinatal slagtilfælde
-
Fundación IVIRekrutteringPerinatal lidelseSpanien, Italien, Det Forenede Kongerige
-
Weill Medical College of Cornell UniversityRekrutteringPerinatal depression | Perinatal angstForenede Stater
-
Massachusetts General HospitalPositive Intelligence Inc.Ikke rekrutterer endnuPerinatal depression | Perinatal angst
-
University of PennsylvaniaNational Institute of Nursing Research (NINR)RekrutteringSygelighed; PerinatalForenede Stater
-
IRCCS Burlo GarofoloRekrutteringPerinatal plejeItalien
-
PulseNmoreAfsluttet
-
Universite du Quebec en OutaouaisFonds de la Recherche en Santé du Québec; Canadian Research Chair in Family...Ukendt
-
University Tunis El ManarAfsluttet
-
Sameera ShafiqIkke rekrutterer endnu
-
King's College LondonAga Khan University; UK Research and Innovation; Centro Internacional para...Ikke rekrutterer endnu
Kliniske forsøg med Increased protein
-
Anglia Ruskin UniversityDanone Nutricia ResearchRekrutteringGastrointestinal dysfunktion | AminosyreændringDet Forenede Kongerige
-
USDA Grand Forks Human Nutrition Research CenterAktiv, ikke rekrutterendeFedmeForenede Stater
-
University of AarhusArla Foods; Mejeribrugets ForskningsFond; Innovation foundationAfsluttetProteinmetabolismeDanmark
-
USDA Grand Forks Human Nutrition Research CenterNorth Dakota Beef CommissionAfsluttet
-
Arne AstrupAfsluttetUndersøgelsesfokus: AppetitDanmark
-
Pennington Biomedical Research CenterAfsluttet
-
University of KielAfsluttet
-
University of UtahAfsluttet
-
University of ExeterAfsluttetSund og raskDet Forenede Kongerige
-
Assiut UniversityIkke rekrutterer endnu