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Набор по приглашению NCT06415994

Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder

— Наблюдательное Opioid Use Disorder Substance-Related Disorders Pregnancy Related Narcotic-Related Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Buprenorphine or Methadone Treatment, Fetal and Placental MRI, Child Developmental Assessment, Questionnaires.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder, Substance-Related Disorders, Pregnancy Related, Narcotic-Related Disorders. Базовые параметры: 18 лет — 100 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are: * Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment. * To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment. In this study participants will: * Receive two placental-fetal MRIs, one during second trimester and one in third trimester. * Answer surveys relating to their medical and social history. * Have blood drawn during pregnancy and delivery. * Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.

Вмешательства

  • Препарат Buprenorphine or Methadone Treatment
    Pregnant mothers must be taking Buprenorphine or Methadone
  • Диагностический тест Fetal and Placental MRI
    Two MRIs : * Second Trimester * Third Trimester
  • Поведенческое Child Developmental Assessment
    At 1 year of life child will receive a developmental assessment
  • Поведенческое Questionnaires
    Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
  • Другое Blood and Placental Samples
    At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers. At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.

Первичные конечные точки

  • Alterations in fetal brain volume [Срок оценки: Between 20 weeks gestation and delivery]
  • Differences in placenta signal [Срок оценки: Between 20 weeks gestation and delivery]
Вторичные конечные точки (6)
  • Placental epigenetic changes related to POE [Срок оценки: Between 20 weeks gestation and delivery]
  • Placental dysfunction biomarkers related to POE [Срок оценки: Between 20 weeks gestation and delivery]
  • Neonatal Opioid Withdrawal Syndrome (NOWS) severity [Срок оценки: After birth through one year of life]
  • Length of Hospital Stay [Срок оценки: After birth through one year of life]
  • Ages and Stages Questionnaire Scores during infancy [Срок оценки: After birth through one year of life]
  • Neurocognitive and behavioral development assessment (Bayley-4) at one year of age [Срок оценки: After birth through one year of life]

Критерии участия

Pregnant women with opioid use disorder

Критерии включения

  • Age >18 years
  • Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
  • Singleton Pregnancy
  • Planned delivery at Indiana University or University of Pittsburgh study sites

Критерии исключения

  • Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
  • Known or suspected major fetal/ neonatal congenital abnormalities
  • HIV or AIDS

Infants with prenatal opioid exposure:

Inclusion:

  • Prenatal buprenorphine or methadone exposure
  • Born to mother enrolled in Opioid Use Disorder arm of study

Exclusion:

Major congenital anomalies or genetic syndromes affecting neurodevelopment

Control Pregnant Women:

Inclusion:

  • Women >18 Years of age
  • Healthy singleton pregnancy
  • Planned delivery at Indiana University or University of Pittsburgh study sites

Exclusion:

  • Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
  • HIV or AIDS
  • Known or suspected major fetal congenital abnormalities
  • Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.

Control infants:

Inclusion:

Born to control pregnant mother enrolled in study

Exclusion:

Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • Riley Hospital for Children — Indianapolis
  • University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06415994 · STUDY23110104 · R01DA059321 · RADY-IIR-19751

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗