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Optimering af farmakologisk behandling for neonatalt opioidabstinenssyndrom (OPTIMER NU): En symptombaseret doseringsmetode (OPTimize NOW)

13. maj 2026 opdateret af: HELP for NOWS Consortium

Dette kliniske forsøg vil hjælpe os med at lære mere om, hvordan man bedst plejer babyer med neonatalt opioidabstinenssyndrom, også kaldet NOWS. Babyer med NUWS har ofte rystelser, svært ved at sove, overdreven gråd og problemer med at spise. Nogle babyer, der har NU, har brug for medicin. Læger har to måder at give medicin på, som er meget udbredt i dag:

  1. Planlagt opioidtrapstilgang. Barnet får medicin på faste tidspunkter. Efterhånden som symptomerne bliver bedre, falder mængden af ​​medicin, barnet får, indtil barnet ikke længere har brug for medicin. Dette kaldes en medicintilspidsning.
  2. Symptombaseret tilgang. Babyen får først medicin, når de viser tegn på NU, i stedet for på almindelige tidspunkter. Hvis barnet ikke viser tegn på NU, vil der ikke blive givet medicin.

Vi laver OPTimize NOW-undersøgelsen for at finde ud af den bedste måde at give medicin til babyer med NOWS.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette to-perioders cluster crossover kliniske forsøg vil sammenligne længden af ​​tiden fra fødslen til medicinsk klar til udskrivning mellem spædbørn med neonatalt opioidabstinenssyndrom (NOWS), som er ≥ 36 ugers svangerskab, i risiko for farmakologisk behandling og behandlet for NOWS med enten en symptombaseret doseringstilgang eller en planlagt opioidnedtrapningstilgang.

Hvert undersøgelsessted (dvs. klynge) vil blive randomiseret i et 1:1 tildelingsforhold til en af ​​to sekvenser:

  • Planlagt opioid-nedtrapningstilgang i 5 måneder (periode 1) efterfulgt af en to-ugers udvaskningsperiode efterfulgt af symptombaseret doseringstilgang i 5 måneder (periode 2)
  • Symptombaseret doseringstilgang i 5 måneder (periode 1) efterfulgt af en to-ugers udvaskningsperiode efterfulgt af planlagt opioidnedtrapningstilgang i 5 måneder (periode 2)

Randomiseringsordningen vil blive stratificeret efter vurderings- og ledelsestilgangen, der anvendes på hvert undersøgelsessted (dvs. Finnegan eller Eat, Seep and Console).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

626

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

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

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Spædbarnet er større end eller lig med 36 ugers svangerskab.

  2. Spædbarnet havde prænatal opioideksponering identificeret ved mindst én af følgende:

    • Anamnese med moderens opioidbrug under graviditeten;
    • Positiv maternal toksikologisk screening for opioider under andet eller tredje trimester af graviditeten; og/eller
    • Positiv spædbarnstoksikologisk screening for opioider under det indledende hospitalsophold.
  3. Spædbarnet bliver vurderet og administreret til NOWS på et kvalificeret studiested.

  4. Spædbarnet er i risiko for farmakologisk behandling for NOWS defineret af et af følgende

    • Mindst 1 score ≥ 8, hvis det vurderes og håndteres med FNAST eller modifikation heraf
    • Mindst 1 "ja", hvis det vurderes og håndteres med ESC-plejetilgangen

Ekskluderingskriterier:

  1. Spædbarnet har større fødselsdefekt(er).
  2. Spædbarnet har neonatal encefalopati (inklusive hypoxisk iskæmisk encefalopati), en metabolisk lidelse, slagtilfælde, intrakraniel blødning eller meningitis diagnosticeret før påbegyndelse af farmakologisk behandling.
  3. Spædbarnet modtager respirationsstøtte (enhver form for positivt tryk eller iltbehandling) ved 48 timers alderen.
  4. Spædbarnet har gennemgået større kirurgisk indgreb før eller ved 48 timers alderen.
  5. Spædbarnet har postnatal opioideksponering før påbegyndelse af behandling for NOWS.
  6. Spædbarnet var udfødt, og farmakologisk behandling blev indledt på det overførende hospital.
  7. Spædbarnet vurderes for egnethed under undersøgelsesstedets to-ugers udvaskningsperiode.

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: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Sekvens 1
Denne sekvens vil tildele berettigede deltagere en tre-ugers indkøringsperiode efterfulgt af en planlagt opioid-nedtrapningstilgang i fem måneder efterfulgt af en tre-ugers udvaskningsperiode efterfulgt af symptombaseret doseringstilgang i fem måneder.
Andet: Symptombaseret doseringsmetode
Under denne tilgang til pleje vil alle indskrevne spædbørn med NOWS på undersøgelsesstedet blive behandlet med den symptombaserede doseringstilgang, hvis de opfylder abstinensgrænsen for farmakologisk behandling. Deltagerne kan modtage op til 3 doser af undersøgelsesstedets foretrukne opioid i løbet af en 24-timers periode for at behandle tegn på abstinenser, når tærsklen for farmakologisk intervention er nået. Hvis en 4. dosis er påkrævet inden for en 24-timers periode, vil undersøgelsesstedet gå over til den planlagte opioid-taper-algoritme, der anvendes på undersøgelsesstedet for at fuldføre spædbarnets farmakologiske behandling.
Andet: Planlagt Opioid Taper Approach
Under denne tilgang til pleje vil alle indskrevne spædbørn med NOWS på undersøgelsesstedet blive behandlet med undersøgelsesstedets sædvanlige planlagte opioidnedskæringstilgang, som beskrevet detaljeret i hvert steds behandlingsalgoritme, hvis de opfylder seponeringstærsklen for farmakologisk behandling.
Andet: Sekvens 2
Denne sekvens vil tildele berettigede deltagere til en tre-ugers indkøringsperiode efterfulgt af en symptombaseret doseringstilgang i fem måneder efterfulgt af en tre-ugers udvaskningsperiode efterfulgt af planlagt opioidnedtrapningstilgang i fem måneder.
Andet: Symptombaseret doseringsmetode
Under denne tilgang til pleje vil alle indskrevne spædbørn med NOWS på undersøgelsesstedet blive behandlet med den symptombaserede doseringstilgang, hvis de opfylder abstinensgrænsen for farmakologisk behandling. Deltagerne kan modtage op til 3 doser af undersøgelsesstedets foretrukne opioid i løbet af en 24-timers periode for at behandle tegn på abstinenser, når tærsklen for farmakologisk intervention er nået. Hvis en 4. dosis er påkrævet inden for en 24-timers periode, vil undersøgelsesstedet gå over til den planlagte opioid-taper-algoritme, der anvendes på undersøgelsesstedet for at fuldføre spædbarnets farmakologiske behandling.
Andet: Planlagt Opioid Taper Approach
Under denne tilgang til pleje vil alle indskrevne spædbørn med NOWS på undersøgelsesstedet blive behandlet med undersøgelsesstedets sædvanlige planlagte opioidnedskæringstilgang, som beskrevet detaljeret i hvert steds behandlingsalgoritme, hvis de opfylder seponeringstærsklen for farmakologisk behandling.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

HELP for NOWS Consortium

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Lori Devlin, MD, University of Louisville

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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)

25. marts 2024

Primær færdiggørelse (Faktiske)

27. maj 2025

Studieafslutning (Faktiske)

15. juli 2025

Datoer for studieregistrering

Først indsendt

27. juli 2023

Først indsendt, der opfyldte QC-kriterier

27. juli 2023

Først opslået (Faktiske)

7. august 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data indsamlet til denne undersøgelse vil blive analyseret og opbevaret på DCC, RTI International. NIH Helping to End Addiction Long-term Initiative (HEAL) og NICHD-krav til datadeling vil gælde. NIH har haft en langvarig politik for at dele og gøre offentligheden tilgængelige for resultaterne og resultaterne af de aktiviteter, som det finansierer. I overensstemmelse med disse politikker (tilgængelig på HEAL Public Access and Data Sharing | NIH HEAL Initiative) deler vi afidentificerede data indsamlet til undersøgelsen. Efter undersøgelsen er afsluttet, vil de afidentificerede, arkiverede data blive transmitteret til et NIH HEAL-understøttet depot til brug for andre forskere, inklusive dem uden for undersøgelsen.

IPD-delingstidsramme

Inden for 1 år efter studiets afslutning.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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