- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05191823
Omega Tots Langtidsopfølgning
20. juli 2026 opdateret af: Sarah Keim
Langsigtede virkninger og sikkerhed af DHA+AA-tilskud i småbørn til børn født for tidligt
Dette er en fortsættelsesundersøgelse til Omega Tots-forsøget (NCT01576783).
Formålet med denne undersøgelse er at følge op med deltagere i den oprindelige undersøgelse for at bestemme den langsigtede effekt, som et dagligt fedtsyre-kosttilskud taget i småbørn kan have på børn født for tidligt nu, hvor de er 8,5-10,5 år gamle.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Det overordnede formål med denne undersøgelse er at bestemme de langsigtede virkninger af docosahexaensyre (DHA) plus arachidonsyre (AA) tilskud på generel kognitiv evne, sprog og eksekutiv funktion, og at undersøge genetiske forklaringer på behandlingseffekter, gennem en omfattende studiebesøg med børn og forældre fra Omega Tots forsøgskohorten (NCT01576783).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
377
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Ohio
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Columbus, Ohio, Forenede Stater, 43205
- Nationwide Children's Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 6 år (Barn)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Tidligere deltagelse i Omega Tots (NCT01576783).
- Nuværende alder på 8 år, 180 dage til 10 år, 180 dage.
Ekskluderingskriterier:
- Barn, der er varetægtsfængslet af børnetjenester for deres berettigelsesperiode
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Docosahexaensyre + arachidonsyre
Docosahexaensyre + arachidonsyre (DHA+AA)
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200 mg DHA+ 200 mg AA om dagen i 6 måneder
|
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Placebo komparator: Placebo
Majsolie supplement
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400 mg majsolie om dagen i 6 måneder
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Generel kognitiv evnescore(differentiel evneskalaer, anden udgave-DAS-II)
Tidsramme: Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
Differentiel evneskala-II Generel konceptuel evnevurdering er et mål for generel kognitiv evne og bruges til at vurdere og identificere børns kognitive styrker og svagheder.
Den generelle kognitive evnescore har et spænd fra 30 til 170 (middel=100; SD=15).
En lav score indikerer dårlig præstation, og en høj score indikerer bedste præstation.
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Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
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Executive Function (NIH Toolbox)
Tidsramme: Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
NIH Toolbox Cognition Battery er et multidimensionelt sæt korte målinger, der vurderer kognitiv funktion.
Undertestene Flanker, Dimensional Card Sort og Pattern Comparison måler eksekutiv funktion, behandlingshastighed og opmærksomhed.
Standardscore har et interval fra 30 til 170 (gennemsnit=100; SD=15).
En lav score indikerer dårlig præstation, og en høj score indikerer bedste præstation.
|
Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
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Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth Edition-CELF-5)
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
Clinical evaluation of Language Fundamentals, 5th edition core tests is a comprehensive measure of language and can assess children's written and oral language skills, as well as their reading comprehension.
The core language score has a range from 30 to 170 (mean=100; SD=15).
A low score indicates poor performance, and a high score indicates best performance.
|
A single study visit when the child is between 8.5 years to 10.5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rillet Pegboard Opgave
Tidsramme: Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
Opgaven med Grooved Pegboard måler øje-hånd-koordination og motorisk hastighed ved at kræve, at børn indsætter pløkker i et bræt.
Scoren er tidspunktet for at placere pløkkene.
Hvis barnet når tidsgrænsen på 3 minutter, så er scoren antallet af pløkker.
En hurtigere tid og et lavere antal tapede pinde indikerer bedre ydeevne.
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Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
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Antropometri - Fedt
Tidsramme: Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
For at vurdere børns fedtindhold, bruges en bioelektrisk impedans til at måle kropsfedtprocent.
Barnets højde og vægt vil blive kombineret for at rapportere BMI (kg/m^2).
Disse målinger konverteres til en z-score for alder og køn baseret på Child Growth Standards fra Verdenssundhedsorganisationen.
Z-score angiver antallet af standardafvigelser væk fra gennemsnittet.
En z-score på 0 er lig med gennemsnittet af en referencepopulation (børn af samme alder og køn).
Værdier mindre end 0 indikerer værdier lavere end referencepopulationen, mens værdier større end 0 indikerer værdier højere end referencepopulationen.
|
Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
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NIH Toolbox Friendship Fixed Form
Tidsramme: Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
NIH Toolbox Friendship (Alder 8-17) Fixed Form er et spørgeskema med 5 punkter, der måler peer-relationer og vurderer kvaliteten af forhold til venner og andre bekendte i løbet af den seneste måned.
Scorer vil blive udtrykt som en t-score (interval= [16-68]; middel=50; SD=10), hvor en højere score indikerer stærkere peer-relationer.
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Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
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NIH Toolbox Positiv Peer Interaction Forælder Rapport Fast Form
Tidsramme: Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
NIH Toolbox Positive Peer Interaction Form (Alder 3-12) er et 4-element spørgeskema, der måler børns peer-relationer via forældrerapport.
Scorer vil blive udtrykt som en t-score (interval= [-8-63] ; middel=50; SD=10), hvor en højere score indikerer stærkere peer-relationer.
|
Et enkelt studiebesøg, når barnet er mellem 8,5 år til 10,5 år
|
|
Select Subtest From the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V)
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Weschler Intelligence Scales for Children-V Digit Span and Picture Span subtests assess working memory.
The working memory index composite score has a range from 30-170 (mean=100; SD=15).
A low score indicates poor performance, and a high score indicates best performance.
|
A single study visit when the child is between 8.5 years to 10.5 years
|
|
Select Subtests From the Kaufman Test of Educational Achievement, Third Edition (KTEA-3)
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Kaufman Test of Educational Achievement-3 is an assessment of key academic skills.
The Letter and Word Recognition, Math Computation, Object Naming Facility, and Associative Fluency Subtests measure children's reading, math, and written language skills.
The standard score has a range from 30-170 (mean=100; SD=15).
A low score indicates poor performance, and a high score indicates best performance.
|
A single study visit when the child is between 8.5 years to 10.5 years
|
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Anthropometrics-Body Composition (Height)
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
To assess children's body composition, height (in centimeters) is measured.
This is converted to a z score for age and sex based on Child Growth Standards from the World Health Organization.
The z score indicates the number of standard deviations away from the mean.
A z score of 0 is equal to the mean of a reference population (children the same age and sex).
Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population.
|
A single study visit when the child is between 8.5 years to 10.5 years
|
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Anthropometrics-Body Composition (Weight)
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
To assess children's body composition, weight (in kilograms) is measured.
This is converted to a z score for age and sex based on Child Growth Standards from the World Health Organization.
The z score indicates the number of standard deviations away from the mean.
A z score of 0 is equal to the mean of a reference population (children the same age and sex).
Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population.
|
A single study visit when the child is between 8.5 years to 10.5 years
|
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Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2)
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Behavior Rating Inventory of Executive Function, 2nd ed., is completed by the child's caregiver and teacher to measure a range of executive functioning capabilities in children.
The BRIEF-2 yields nine clinical scales that measure various aspects of executive function plus three broad indices: behavioral regulation, emotion regulation, and cognitive regulation.
Scores are summed to obtain a Global Executive Composite Score that will be expressed as a t score (range= [35-90]; (mean=50; SD=10), where a higher score indicates greater dysregulation .
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A single study visit when the child is between 8.5 years to 10.5 years
|
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Select Subscales From the Teacher Report Form 6-18
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Teacher Report Form (syndrome and DSM-Oriented subscales) is completed by the child's teacher to reflect on the child's behavior in the previous six months.
Scores are summed to provide a total problems score.
Scores are also computed to measure the following subscales: internalizing problems, externalizing problems, anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggression behavior, affective problems, anxiety problems, somatic problems, attention deficit/hyperactivity problems, oppositional defiant problems, conduct problems.
Scores will be expressed as a t-score (range= [33-100]; mean=50; SD=10), where a lower score indicates a more optimal outcome.
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A single study visit when the child is between 8.5 years to 10.5 years
|
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Child Behavior Checklist 6-18 (CBCL) - Competence
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Child Behavior Checklist is completed by the child' caregiver to reflect their child's behavior in the previous six months.
Scores were summed to provide total competence score.
Total competence scores will be expressed as a t-score (range= [20-100]; mean=50; SD=10), where a higher score reflects a more optimal outcome.
|
A single study visit when the child is between 8.5 years to 10.5 years
|
|
National Survey of Children's Health Module - Learning Disability
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report .
A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).
|
A single study visit when the child is between 8.5 years to 10.5 years
|
|
Emotion Regulation Checklist - Emotion Regulation
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Emotion Regulation Checklist is completed by the child's caregiver to measure child's ability to manage their emotions.
Scores are grouped and summed to yield Emotion Regulation scale (range=10-40).
Higher scores on the Emotion Regulation scale indicates more ability to regulate
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A single study visit when the child is between 8.5 years to 10.5 years
|
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Child Sleep Habits Questionnaire-abbreviated Measure
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Child Sleep Habits Questionnaire-abbreviated measures child sleep pattern and behaviors via parent report.
Parents are asked to report on the child's bedtime behavior, sleep duration, and behavior during sleep.
Scores are summed to give the total sleep disturbance score (range 33-99).
Scores are also grouped and summed to yield eight subscales that measure different aspects of sleep.
A higher score is indicative of more sleep problems .
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A single study visit when the child is between 8.5 years to 10.5 years
|
|
Child Behavior Checklist 6-18 (CBCL) - Problems
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Child Behavior Checklist is completed by the child' caregiver to reflect their child's behavior in the previous six months.
Scores were summed to provide problem scores.
T Problem scores will be expressed as a t-score (range= [25,100]; mean=50; SD=10), where a lower score reflects a more optimal outcome.
|
A single study visit when the child is between 8.5 years to 10.5 years
|
|
National Survey of Children's Health Module - Developmental Delay
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report .
A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).
|
A single study visit when the child is between 8.5 years to 10.5 years
|
|
National Survey of Children's Health Module - INtellectual Disability
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report .
A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).
|
A single study visit when the child is between 8.5 years to 10.5 years
|
|
National Survey of Children's Health Module - Speech or Other Language Disorder
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report .
A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).
|
A single study visit when the child is between 8.5 years to 10.5 years
|
|
National Survey of Children's Health Module - Behavioral or Conduct Problems
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report .
A binary variable will be formed to indicate if a child has been diagnosed with each condition or not (yes, no).
|
A single study visit when the child is between 8.5 years to 10.5 years
|
|
Emotion Regulation Checklist - Lability/Negativity
Tidsramme: A single study visit when the child is between 8.5 years to 10.5 years
|
The Emotion Regulation Checklist is completed by the child's caregiver to measure child's ability to manage their emotions.
Scores are grouped and summed to yield a Lability/Negativity (range=14-56) scale.
Higher scores on the Lability/Negativity scale reflect greater dysregulation .
|
A single study visit when the child is between 8.5 years to 10.5 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sarah Keim, PhD, Nationwide Children's Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2021
Primær færdiggørelse (Faktiske)
25. juni 2024
Studieafslutning (Anslået)
30. juni 2027
Datoer for studieregistrering
Først indsendt
21. december 2021
Først indsendt, der opfyldte QC-kriterier
10. januar 2022
Først opslået (Faktiske)
14. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Obstetrisk arbejde, for tidligt
- Obstetriske arbejdskomplikationer
- Graviditetskomplikationer
- For tidlig fødsel
- Fedtsyrer
- Lipider
- Eicosanoider
- Fedtsyrer, umættet
- Olier
- Diætfedt
- Fedt
- Fedtsyrer, Omega-3
- Diætfedt, umættet
- Fiskeolier
- Essentielle Fedtsyrer
- Arachidonic Acids
- Docosahexaenoinsyrer
- Arachidonic Acid
Andre undersøgelses-id-numre
- 00001037
- R01HD100493 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .