- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05779904
Metylering, mikrobiom, ernæringsstatus og utvikling av forkrøplede barn (MINUTES)
DNA-metylering, mikrobiomprofil, ernæringsstatus og utviklingsresultater for barn med forkrøplet og ikke-forkrøplet barn som vokser opp under Covid-19-pandemien: en sakskontrollstudie
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
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Jakarta, Indonesia, 10430
- Seameo Recfon
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inklusjonskriterier:
- i alderen 18,0 - 23,9 måneder
- uten alvorlige sykdommer
- moren fødte barna mellom 18-40 år
- har Sasak etnisitet, (5) liggende lengde <-2SD (for forkrøplet gruppe) og >-1SD (for ikke-forkrøplet gruppe) fra WHO Child Growth Standards median for deres alder og kjønn ved rekrutteringen.
Ekskluderingskriterier:
- tvillingfødsel
- medfødt misdannelse
- slektskap
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Stunted (sak)
I casegruppen vil forkrøplede barn (<-2SD) (n=150) rekrutteres.
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Ikke-hemmet (kontroll)
I kontrollgruppen vil ikke-forkrøplede barn (>-1SD) (n=150) rekrutteres.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Epigenetikksignatur relatert til stunting
Tidsramme: ved påmelding
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Analyse av epigenetiske tilstander (DNA-metylering) vil bli utført ved bruk av Illumina Infinium Methylation EPIC V.2.0 BeadChip, forsterket med sekvenseringsmetodologier for å gi både genombred dekning og høydefinisjonsanalyse.
Epigenetisk tilstand kontrollerer genuttrykk og generell genomregulering i stor skala, og studien vil fokusere på kandidat epigenetiske tilstander implisert i stunting og dets konsekvenser sammen med epigenom bred assosiasjon.
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ved påmelding
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Utfall av kjennskap til barn (av psykologer)
Tidsramme: ved påmelding
|
Kognitiv utvikling vil bli vurdert ved hjelp av hele Bayley Scales of Infant and Toddler Development (BSID-4) av trente psykologer. BSID-4 består av: Kognitiv skala (COG); Språkskala (LANG) og Motorisk skala (MOT). Utvalget av standard poengsum (SS) på hver skala er 40-160, der høyere poengsum betyr bedre. |
ved påmelding
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Kognisjonsutfall for barn (omsorgsgiver rapportert)
Tidsramme: ved påmelding
|
Kognitiv utvikling vil bli vurdert ved hjelp av omsorgsgiver-rapportert verktøy, dvs. INTERGROWTH-21st Neurodevelopment assessment INTER-NDA av trente tellere. INTER-NDA består av: Kognitiv; Fin motor; Grovmotorisk; Språk; Positiv oppførsel; Negativ oppførsel. Utvalget av poengsum på hver skala er 0 - 100, der høyere poengsum betyr bedre. |
ved påmelding
|
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Tarmmikrobiom
Tidsramme: ved påmelding
|
Fekalt mikrobiom vil bli analysert ved bruk av 16S RNA-sekvensering av V4-regionen på Illumina MiSeq-plattformen
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ved påmelding
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Umi Fahmida, Dr., Seameo Recfon
Publikasjoner og nyttige lenker
Generelle publikasjoner
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Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
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Nøkkelord
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