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Active, Not Recruiting

NCT Number: NCT04149509

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neonatal Opioid Withdrawal Syndrome

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Exposed infants: Born ≥37 weeks gestation with second or third trimester opioid exposure
  • Control infants: Born ≥37 weeks gestation with no antenatal drug exposure

Exclusion criteria

  • Infants with known chromosomal or congenital anomalies potentially affecting the central nervous system
  • Apgar score at 5 minutes of <5
  • Any requirement for positive pressure ventilation in the NICU
  • Inability to return for outpatient MRI and/or follow-up
  • IUGR <3rd percentile
  • Heavy alcohol use during pregnancy (8+ drinks per week).

Treatment and study plan

Primary outcomes

  1. Primary outcome related to brain development: White Matter Volume

    Time frame: Birth to 22-24 months of age

    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.

  2. Primary outcome related to brain development: Cortical Gray Matter Volume

    Time frame: Birth to 22-24 months of age

    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.

  3. Primary outcome related to brain development: Deep Gray Matter Volume

    Time frame: Birth to 22-24 months of age

    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.

  4. Primary outcome related to brain development: Lateral Ventricle Volume

    Time frame: Birth to 22-24 months of age

    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.

  5. Primary outcome related to brain development: External cerebrospinal fluid

    Time frame: Birth to 22-24 months of age

    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.

  6. Primary outcome related to behavioral and development: Bayley Scales of Infant Development

    Time frame: 22-24 months of age

    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.

  7. Primary outcome related to behavioral and development: Spot Vision Screener

    Time frame: 22-24 months of age

    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.

  8. Primary outcome related to behavioral and development: BITSEA

    Time frame: 22-24 months of age

    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.

Sponsors and collaborators

Lead sponsor

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

Network

Collaborators

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

Registry information

Acronym: OBOE

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2019
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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