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Optimalisering av farmakologisk behandling for neonatalt opioidabstinenssyndrom (OPTIMER NÅ): En symptombasert doseringsmetode (OPTimize NOW)

13. mai 2026 oppdatert av: HELP for NOWS Consortium

Denne kliniske studien vil hjelpe oss med å lære mer om hvordan vi best tar vare på babyer med neonatalt opioidabstinenssyndrom, også kalt NOWS. Babyer med NOW har ofte skjelvinger, vanskelig å sove, overdreven gråt og problemer med å spise. Noen babyer som har NOW trenger medisin. Leger har to måter å gi medisin på som er mye brukt i dag:

  1. Planlagt opioidnedskjæring. Babyen får medisin til faste tider. Etter hvert som symptomene blir bedre, reduseres mengden medisin babyen får til babyen ikke lenger trenger medisin. Dette kalles en medisinsk taper.
  2. Symptombasert tilnærming. Babyen vil bare få medisin når de viser tegn til NÅ, i stedet for til faste tider. Hvis babyen ikke viser tegn til NOW, vil ingen medisin bli gitt.

Vi gjør OPTimize NOW-studien for å finne ut den beste måten å gi medisin til babyer med NOWS.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Denne to-perioders cluster crossover-studien vil sammenligne tiden fra fødsel til medisinsk utskrivningsklarhet mellom spedbarn med neonatalt opioidabstinenssyndrom (NOWS) som er ≥ 36 ukers svangerskap, i fare for farmakologisk behandling, og behandlet for NOWS med enten en symptombasert doseringstilnærming eller en planlagt opioidnedtrapping.

Hvert studiested (dvs. klynge) vil bli randomisert i et tildelingsforhold på 1:1 til en av to sekvenser:

  • Planlagt opioidnedtrapping i 5 måneder (periode 1) etterfulgt av en to ukers utvaskingsperiode etterfulgt av symptombasert doseringstilnærming i 5 måneder (periode 2)
  • Symptombasert doseringstilnærming i 5 måneder (periode 1) etterfulgt av en to-ukers utvaskingsperiode etterfulgt av planlagt opioidnedtrapping i 5 måneder (periode 2)

Randomiseringsordningen vil bli stratifisert etter vurderings- og ledelsestilnærmingen som brukes på hvert studiested (dvs. Finnegan eller Eat, Seep and Console).

Studietype

Intervensjonell

Registrering (Faktiske)

626

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • University of Arkansas for Medical Sciences
    • Delaware
      • Wilmington, Delaware, Forente stater, 19801
        • ChristianaCare
    • Florida
      • Tampa, Florida, Forente stater, 33606
        • University of South Florida Health
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Sidney & Lois Eskenazi Hospital
      • Jeffersonville, Indiana, Forente stater, 47130
        • University of Louisville Hospital
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Hospital
    • Kentucky
      • Edgewood, Kentucky, Forente stater, 41017
        • St. Elizabeth Healthcare
      • Lexington, Kentucky, Forente stater, 40536
        • Kentucky Children's Hospital
      • Louisville, Kentucky, Forente stater, 40202
        • Norton Children's Hospital
      • Louisville, Kentucky, Forente stater, 40207
        • Norton Women's and Children's Hospital
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Atlantic City, New Jersey, Forente stater, 08401
        • AtlantiCare Regional Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87131
        • University of New Mexico Health Sciences Center
    • New York
      • Rochester, New York, Forente stater, 14642
        • University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, Forente stater, 45202
        • Good Samaritan Hospital
      • Kettering, Ohio, Forente stater, 45429
        • Kettering Health Main Campus
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Oklahoma Children's Hospital OU Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Pennsylvania Hospital
    • Utah
      • Salt Lake City, Utah, Forente stater, 84158
        • University of Utah Health

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

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. Spedbarnet er større enn eller lik 36 ukers svangerskap.

  2. Spedbarnet hadde prenatal opioideksponering identifisert av minst ett av følgende:

    • Historie om mors opioidbruk under graviditet;
    • Positiv maternal toksikologisk screening for opioider under andre eller tredje trimester av svangerskapet; og/eller
    • Positiv spedbarnstoksikologisk screening for opioider under det første sykehusoppholdet.
  3. Spedbarnet blir vurdert og administrert for NOW på et kvalifisert studiested.

  4. Spedbarnet er i fare for farmakologisk behandling for NOWS definert av ett av følgende

    • Minst 1 poengsum ≥ 8 hvis vurdert og administrert med FNAST eller modifikasjon av dette
    • Minst 1 "ja" hvis det vurderes og håndteres med ESC-pleietilnærmingen

Ekskluderingskriterier:

  1. Spedbarnet har store fødselsskader.
  2. Spedbarnet har neonatal encefalopati (inkludert hypoksisk iskemisk encefalopati), en metabolsk forstyrrelse, hjerneslag, intrakraniell blødning eller meningitt diagnostisert før oppstart av farmakologisk behandling.
  3. Spedbarnet mottar respirasjonsstøtte (enhver form for positivt trykk eller oksygenbehandling) ved 48 timers alder.
  4. Spedbarnet har gjennomgått store kirurgiske inngrep før eller ved 48 timers alder.
  5. Spedbarnet har postnatal opioideksponering før oppstart av behandling for NOWS.
  6. Spedbarnet var utfødt og farmakologisk behandling ble igangsatt på det overførende sykehuset.
  7. Spedbarnet vurderes for kvalifisering i løpet av studiestedets to ukers utvaskingsperiode.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Sekvens 1
Denne sekvensen vil tilordne kvalifiserte deltakere til en tre ukers innkjøringsperiode etterfulgt av en planlagt opioidtilnærming i fem måneder etterfulgt av en tre ukers utvaskingsperiode etterfulgt av symptombasert doseringsmetode i fem måneder.
Annen: Symptombasert doseringsmetode
I løpet av denne tilnærmingen til omsorg vil alle registrerte spedbarn med NOWS på studiestedet bli behandlet med den symptombaserte doseringstilnærmingen hvis de oppfyller abstinensgrensen for farmakologisk behandling. Deltakerne kan motta opptil 3 doser av studiestedets foretrukne opioid i løpet av en 24-timers periode for å behandle tegn på abstinens når terskelen for farmakologisk intervensjon er nådd. Hvis en fjerde dose er nødvendig innen en 24-timers periode, vil studiestedet gå over til den planlagte opioidavsmalningsalgoritmen som brukes på studiestedet for å fullføre spedbarnets farmakologiske behandling.
Annen: Planlagt opioidtilnærming
I løpet av denne tilnærmingen til omsorg, vil alle registrerte spedbarn med NOWS på studiestedet bli behandlet med studiestedets vanlige planlagte opioidavsmalnende tilnærming, som beskrevet i hver sides behandlingsalgoritme, hvis de oppfyller seponeringsterskelen for farmakologisk behandling.
Annen: Sekvens 2
Denne sekvensen vil tilordne kvalifiserte deltakere til en tre ukers innkjøringsperiode etterfulgt av en symptombasert doseringstilnærming i fem måneder etterfulgt av en tre ukers utvaskingsperiode etterfulgt av planlagt opioidnedtrapping i fem måneder.
Annen: Symptombasert doseringsmetode
I løpet av denne tilnærmingen til omsorg vil alle registrerte spedbarn med NOWS på studiestedet bli behandlet med den symptombaserte doseringstilnærmingen hvis de oppfyller abstinensgrensen for farmakologisk behandling. Deltakerne kan motta opptil 3 doser av studiestedets foretrukne opioid i løpet av en 24-timers periode for å behandle tegn på abstinens når terskelen for farmakologisk intervensjon er nådd. Hvis en fjerde dose er nødvendig innen en 24-timers periode, vil studiestedet gå over til den planlagte opioidavsmalningsalgoritmen som brukes på studiestedet for å fullføre spedbarnets farmakologiske behandling.
Annen: Planlagt opioidtilnærming
I løpet av denne tilnærmingen til omsorg, vil alle registrerte spedbarn med NOWS på studiestedet bli behandlet med studiestedets vanlige planlagte opioidavsmalnende tilnærming, som beskrevet i hver sides behandlingsalgoritme, hvis de oppfyller seponeringsterskelen for farmakologisk behandling.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time from birth until medically ready for discharge (ESC cohort only)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.

Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria:

  • ≥ 96 hours of age
  • ≥ 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)

This primary outcome is for infants assessed and managed using ESC.
From date of birth until hospital discharge or 1 year, whichever comes first.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time from birth until medically ready for discharge (Finnegan Cohort only)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.

Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria:

  • 96 hours of age
  • 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)

This secondary outcome is for infants assessed and managed using Finnegan.
From date of birth until hospital discharge or 1 year, whichever comes first.
Receipt of pharmacologic treatment (ESC Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
If the infant received opioid replacement therapy prior to hospital discharge and was managed using ESC.
From date of birth until hospital discharge or 1 year, whichever comes first.
Length of hospital stay (ESC Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
Number of days infant remained in the hospital and managed with ESC.
From date of birth until hospital discharge or 1 year, whichever comes first.
Total number opioid doses (ESC Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
The total number of opioid doses administered among infants managed with ESC and pharmacologically treated during initial hospitalization.
From date of birth until hospital discharge or 1 year, whichever comes first.
Receipt of secondary medications (ESC Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
The total number of secondary opioid doses administered among infants managed with ESC and pharmacologically treated during initial hospitalization.
From date of birth until hospital discharge or 1 year, whichever comes first.
Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach (ESC Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
The total number of infants managed with ESC and pharmacologically treated during initial hospitalization who transitioned from a symptom-based dosing approach to a scheduled opioid taper approach
From date of birth until hospital discharge or 1 year, whichever comes first.
Stopped scheduled opioid taper treatment (ESC Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
The total number of infants managed with ESC and pharmacologically treated during initial hospitalization who were initially treated with a scheduled opioid taper but stopped treatment due to excessive sedation or respiratory depression
From date of birth until hospital discharge or 1 year, whichever comes first.
Receipt of pharmacologic treatment (Finnegan Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
If the infant received opioid replacement therapy prior to hospital discharge and was managed using Finnegan.
From date of birth until hospital discharge or 1 year, whichever comes first.
Length of hospital stay (Finnegan Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
Number of days infant remained in the hospital and managed with Finnegan.
From date of birth until hospital discharge or 1 year, whichever comes first.
Total number opioid doses (Finnegan Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
The total number of opioid doses administered among infants managed with Finnegan and pharmacologically treated during initial hospitalization.
From date of birth until hospital discharge or 1 year, whichever comes first.
Receipt of secondary medications (Finnegan Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
The total number of secondary opioid doses administered among infants managed with Finnegan and pharmacologically treated during initial hospitalization.
From date of birth until hospital discharge or 1 year, whichever comes first.
Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach (Finnegan Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
The total number of infants managed with Finnegan and pharmacologically treated during initial hospitalization who transitioned from a symptom-based dosing approach to a scheduled opioid taper approach
From date of birth until hospital discharge or 1 year, whichever comes first.
Stopped scheduled opioid taper treatment (Finnegan Cohort)
Tidsramme: From date of birth until hospital discharge or 1 year, whichever comes first.
The total number of infants managed with Finnegan and pharmacologically treated during initial hospitalization who were initially treated with a scheduled opioid taper but stopped treatment due to excessive sedation or respiratory depression
From date of birth until hospital discharge or 1 year, whichever comes first.
Inpatient Composite Safety Outcome for infants at risk for pharmacologic treatment, managed with ESC (present/absent)
Tidsramme: From date of birth until hospital discharge
A composite safety outcome for infants at risk for pharmacologic treatment, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures, Excessive weight loss >15% from birthweight
From date of birth until hospital discharge
Inpatient Composite Safety Outcome for infants at risk for pharmacologic treatment, managed with Finnegan (present/absent)
Tidsramme: From birth until hospital discharge
A composite safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Seizures, Excessive weight loss >15% from birthweight
From birth until hospital discharge
Inpatient Composite Critical Safety Outcome for infants at risk for pharmacologic treatment, managed with ESC (present/absent)
Tidsramme: From birth until hospital discharge
A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death
From birth until hospital discharge
Inpatient Composite Critical Safety Outcome for infants at risk for pharmacologic treatment, managed with Finnegan (present/absent)
Tidsramme: A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death
From birth until hospital discharge
A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death
Outpatient Composite Safety Outcome at risk for pharmacologic treatment, managed with ESC (present/absent)
Tidsramme: From hospital discharge to 3 months of age
A composite outpatient safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits, Hospital readmissions
From hospital discharge to 3 months of age
Outpatient Composite Safety Outcome at risk for pharmacologic treatment, managed with Finnegan (present/absent)
Tidsramme: From hospital discharge to 3 months of age
A composite outpatient safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits, Hospital readmissions
From hospital discharge to 3 months of age
Outpatient Composite Critical Safety Outcome at risk for pharmacologic treatment, managed with ESC (present/absent)
Tidsramme: From hospital discharge to 3 months of age
A composite critical outpatient safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma, Death
From hospital discharge to 3 months of age
Outpatient Composite Critical Safety Outcome at risk for pharmacologic treatment, managed with Finnegan (present/absent)
Tidsramme: From hospital discharge to 3 months of age
A composite critical outpatient safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma, Death
From hospital discharge to 3 months of age
Inpatient Composite Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)
Tidsramme: From birth to hospital discharge
A composite safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures; Excessive weight loss >15% from birthweight
From birth to hospital discharge
Inpatient Composite Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)
Tidsramme: From birth to hospital discharge
A composite safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures; Excessive weight loss >15% from birthweight.
From birth to hospital discharge
Inpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)
Tidsramme: From birth to hospital discharge
A composite critical safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma; Death.
From birth to hospital discharge
Inpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)
Tidsramme: From birth to hospital discharge
A composite critical safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma; Death.
From birth to hospital discharge
Outpatient Composite Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)
Tidsramme: From hospital discharge to 3 months of age
A composite outpatient safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits; Hospital readmissions.
From hospital discharge to 3 months of age
Outpatient Composite Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent
Tidsramme: From hospital discharge to 3 months of age
A composite outpatient safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits; Hospital readmissions.
From hospital discharge to 3 months of age
Outpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)
Tidsramme: From hospital discharge to 3 months of age
A composite critical outpatient safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma; Death.
From hospital discharge to 3 months of age
Outpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)
Tidsramme: From hospital discharge to 3 months of age
A composite critical outpatient safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma; Death.
From hospital discharge to 3 months of age

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

HELP for NOWS Consortium

Samarbeidspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)

Etterforskere

  • Hovedetterforsker: Lori Devlin, MD, University of Louisville

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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 (Faktiske)

25. mars 2024

Primær fullføring (Faktiske)

27. mai 2025

Studiet fullført (Faktiske)

15. juli 2025

Datoer for studieregistrering

Først innsendt

27. juli 2023

Først innsendt som oppfylte QC-kriteriene

27. juli 2023

Først lagt ut (Faktiske)

7. august 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HELP for NOWS 02
  • 1U24HD107621 (U.S. NIH-stipend/kontrakt)
  • 1UG1HD107628 (U.S. NIH-stipend/kontrakt)
  • 1UG1HD107580 (U.S. NIH-stipend/kontrakt)
  • 1UG1HD107649 (U.S. NIH-stipend/kontrakt)
  • 1UG1HD107650 (U.S. NIH-stipend/kontrakt)
  • 1UG1HD107653 (U.S. NIH-stipend/kontrakt)
  • 1UG1HD107627 (U.S. NIH-stipend/kontrakt)
  • 1UG1HD107631 (U.S. NIH-stipend/kontrakt)
  • 1UG1HD107616 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Data samlet inn for denne studien vil bli analysert og lagret ved DCC, RTI International. NIH Helping to End Addiction Long-term Initiative (HEAL) og NICHD-krav for datadeling vil gjelde. NIH har hatt en langvarig policy for å dele og gjøre tilgjengelig for publikum resultatene og prestasjonene av aktivitetene de finansierer. I samsvar med disse retningslinjene (tilgjengelig på HEAL Public Access and Data Sharing | NIH HEAL Initiative), vil vi dele avidentifiserte data som samles inn for studien. Etter at studien er fullført, vil de avidentifiserte, arkiverte dataene bli overført til et NIH HEAL-støttet depot, for bruk av andre forskere, inkludert de utenfor studien.

IPD-delingstidsramme

Innen 1 år etter fullført studie.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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