The objective of this longitudinal cohort study is to quantify the effects of antenatal
      opioid exposure on the trajectory of brain development over the first 2 years of life,
      examine associations with developmental and neurobehavioral outcomes, and explore how
      specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid
      withdrawal, maternal stress/depression/parenting) modify these effects

ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study

Neonatal Opioid Withdrawal Syndrome

This objective of this longitudinal cohort study is to prospectively examine the medical,
      neuroanatomical, neurodevelopmental, behavioral, and social/family/home outcomes of infants
      who were exposed to opioids in utero. Match control infants will be recruited into the study
      and based on birth hospital and birth month of the exposed infants. The study will quantify
      the effects of antenatal opioid exposure on the trajectory of brain development over the
      first 2 years of life, examine associations with developmental and neurobehavioral outcomes,
      and explore how specific factors (differing antenatal and postnatal exposures, severity of
      neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects. The
      investigators hypothesize that neural connectivity and neuroanatomical volumes are altered by
      antenatal opioid exposure and that the magnitude of these alterations correlates with
      developmental and behavioral outcomes. Further, maternal and environmental factors interact
      with antenatal opioid exposure to influence the trajectories of connectivity, development,
      and behavior over the first 2 years of life.

Volumetric analysis will be done with the white matter volume obtained from each of the MRI images collected from birth until 22-24 months of age. The differences between the exposed and non-exposed groups will be calculated.

Volumetric analysis will be done with the cortical gray matter volume obtained from each of the MRI images collected from birth until 22-24 months of age. The differences between the exposed and non-exposed groups will be calculated.

Volumetric analysis will be done with the deep gray matter volume obtained from each of the MRI images collected from birth until 22-24 months of age. The differences between the exposed and non-exposed groups will be calculated.

Volumetric analysis will be done with the lateral ventricle volume obtained from each of the MRI images collected from birth until 22-24 months of age. The differences between the exposed and non-exposed groups will be calculated.

Volumetric analysis will be done with the external cerebrospinal fluid volume obtained from each of the MRI images collected from birth until 22-24 months of age. The differences between the exposed and non-exposed groups will be calculated.

The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.

The vision screener and auto-refractor detects amblyopia risk factors such as myopia, hyperopia, astigmatism, anisometropia, gaze, and anisocoria. Results are reported as "all measurements in range-pass" or "complete eye exam recommended-fail" based on manufacturer criteria for age. If the screen recommends a complete eye exam, the reason for failure (of the 6 factors listed above) and affected eye(s) will be recorded.

Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit.

Infants born ≥ 37 weeks gestation with second or third trimester opioid exposure as determined by maternal urine toxicology screen at delivery; maternal history; and/or infant urine, meconium, or umbilical cord toxicology screen.

Infants born ≥ 37 weeks gestation with no antenatal drug exposure as determined by maternal urine toxicology screen at delivery and/or maternal history. We will match control infants to exposed infants based on Clinical Site and up to 60 days after the date of birth of the exposed infant , recruiting 1 control for every other exposed infant at each site.

ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status