4/7: Longitudinal Evaluation of the Impact of the COVID-19 Pandemic on High-risk New and Expectant Mothers

  • Funded by National Institutes of Health (NIH)
  • Total publications:0 publications

Grant number: 3R34DA050290-01S2

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2019
    2021
  • Known Financial Commitments (USD)

    $158,349
  • Funder

    National Institutes of Health (NIH)
  • Principle Investigator

    Pending
  • Research Location

    United States of America, Americas
  • Lead Research Institution

    UNIVERSITY OF PITTSBURGH AT PITTSBURGH
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Prognostic factors for disease severity

  • Special Interest Tags

    Gender

  • Study Subject

    Clinical

  • Clinical Trial Details

    Not applicable

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)

  • Vulnerable Population

    Drug usersPregnant women

  • Occupations of Interest

    Unspecified

Abstract

While the rate of neonatal abstinence syndrome has reached a staggering 6.5 per 1,000 births nationwide, theshort- and long-term effects of in-utero opioid exposure are far from clear. We lack fundamental knowledge ofneurotypical neonatal development and struggle to disentangle the effect of opioid exposure from otherprotective and risk factors impacting infant health. The fetal stage of brain development is a critical periodwhen foundational aspects of brain structure and function are being established. In addition, postnatal braindevelopment and specialization are shaped by environmental experiences thus allowing maturation to beinfluenced by lifestyle factors associated with opioid use. This Phase I project will plan for a large scale, multi-site research study to prospectively examine human brain, cognitive, behavioral, social, and emotionaldevelopment beginning prenatally through childhood. The University of Pittsburgh is one of four linked sitesincluding Oregon Health and Sciences University, New York University and the University of Vermont that willaddress key challenges critical to the success of the planned Phase II study. Aim 1 will develop, implementand evaluate innovative recruitment and retention strategies for high-risk populations through a longitudinalsurvey of 150 pregnant women per site (n=600 across sites), half of whom are opioid using. Aim 2 willimplement a multi-site, standardized, longitudinal research protocol by enrolling 20 pregnant women per site(n=80 across sites), half of whom are opioid using. This prospective longitudinal study will collect fetal andneonatal multimodal MRI, biospecimens, and maternal psychosocial and health assessments. Aim 3 willevaluate data acquisition, processing, and statistical considerations to maximize data quality, usability, andintegration across sites. We will test the efficacy of (A) real-time motion monitoring/quality assessment forimproving overall data quality and (B) time-savings versus MRI quality using new acceleration sequenceprotocols. This approach will inform and set a strong foundation for a comprehensive and effective Phase IIresearch plan. The University of Pittsburgh site is led by a highly productive, NIH-funded investigative teamwith multidisciplinary expertise in substance use (Krans, Bogen), pregnancy (Krans), and fetal, neonatal, andpediatric neuroimaging (Luna, Panigrahy). Specifically, our team has established study protocols that yieldexcellent recruitment (~76%) and retention (~74%) rates among opioid using pregnant women, has substantialexperience with imaging the immature brain (fetal/neonatal) and is a leader in developmental cognitiveneuroscience using multimodal imaging to investigate neural mechanisms underlying neurocognitivedevelopment through adolescence. We will leverage our on-going, NIH-funded, multi-center neuroimagingstudies to provide imaging harmonization techniques and assist with the development of structural fetal brainand placental imaging pipeline for all linked sites to assistant with development of Phase II protocol. Further,we will pilot innovative studies of age-related Iron deposition and quantitative fetal MR spectroscopy.