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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA059321 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:
In this study participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | 150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment |
| |
| Pregnant Mothers | 100 pregnant mother who to not have a history of opioid use disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine or Methadone Treatment | Drug | Pregnant mothers must be taking Buprenorphine or Methadone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alterations in fetal brain volume | Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls | Between 20 weeks gestation and delivery |
| Differences in placenta signal | Comparing differences in placenta signal using MRI between the POE group and controls | Between 20 weeks gestation and delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Placental epigenetic changes related to POE | Compare placental DNA methylation in POE group and control group | Between 20 weeks gestation and delivery |
| Placental dysfunction biomarkers related to POE |
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Pregnant women with opioid use disorder
Inclusion Criteria:
Exclusion Criteria:
Infants with prenatal opioid exposure:
Inclusion:
Exclusion:
Major congenital anomalies or genetic syndromes affecting neurodevelopment
Control Pregnant Women:
Inclusion:
Exclusion:
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.
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Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States | ||
| University of Pittsburg |
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Blood samples will be collected at MRI visits for substances, DNA, RNA and epigenetic analysis.
Placental sample: A sample of the placenta will be collected during delivery for analysis DNA, RNA and epigenetic analysis.
| Fetal and Placental MRI | Diagnostic Test | Two MRIs :
|
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| Child Developmental Assessment | Behavioral | At 1 year of life child will receive a developmental assessment |
|
| Questionnaires | Behavioral | Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development |
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| Blood and Placental Samples | Other | 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. |
|
Compare concentrations of blood proteins in POE group vs controls
| Between 20 weeks gestation and delivery |
| Neonatal Opioid Withdrawal Syndrome (NOWS) severity | Measuring NOWs severity in the POE group using eat sleep console scores | After birth through one year of life |
| Length of Hospital Stay | Measuring NOWs severity in the POE group using length of hospital stay | After birth through one year of life |
| Ages and Stages Questionnaire Scores during infancy | Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track. | After birth through one year of life |
| Neurocognitive and behavioral development assessment (Bayley-4) at one year of age | Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children. | After birth through one year of life |
| Pittsburgh |
| Pennsylvania |
| 15260 |
| United States |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D011795 | Surveys and Questionnaires |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
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