OBOE: ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Exposed 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. |
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| Unexposed - Controls 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. |
Outcome Measures
Primary Outcome Measures
- Primary outcome related to brain development: White Matter Volume [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.
- Primary outcome related to brain development: Cortical Gray Matter Volume [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.
- Primary outcome related to brain development: Deep Gray Matter Volume [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.
- Primary outcome related to brain development: Lateral Ventricle Volume [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.
- Primary outcome related to brain development: External cerebrospinal fluid [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.
- Primary outcome related to behavioral and development: Bayley Scales of Infant Development [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.
- Primary outcome related to behavioral and development: Spot Vision Screener [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.
- Primary outcome related to behavioral and development: BITSEA [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Exposed infants: Born ≥37 weeks gestation with second or third trimester opioid exposure
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Control infants: Born ≥37 weeks gestation with no antenatal drug exposure
Exclusion Criteria:
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Infants with known chromosomal or congenital anomalies potentially affecting the central nervous system
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Apgar score at 5 minutes of <5
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Any requirement for positive pressure ventilation in the NICU
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Inability to return for outpatient MRI and/or follow-up
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IUGR <3rd percentile
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Heavy alcohol use during pregnancy (8+ drinks per week).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 3 | RTI International | Durham | North Carolina | United States | 27705 |
| 4 | Cincinnati Children's Medical Center | Cincinnati | Ohio | United States | 45267 |
| 5 | Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | United States | 44106 |
| 6 | Univeristy of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Study Director: Carla Bann, PhD, RTI International
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACTNOW-03
- 1PL1HD101059-01
- RL1HD104251
- RL1HD104252
- RL1HD104253
- RL1HD104254