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| ID | Type | Description | Link |
|---|---|---|---|
| 1PL1HD101059-01 | U.S. NIH Grant/Contract | View source | |
| RL1HD104251 | U.S. NIH Grant/Contract | View source | |
| RL1HD104252 | U.S. NIH Grant/Contract | View source | |
| RL1HD104253 | U.S. NIH Grant/Contract | View source | |
| RL1HD104254 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome related to brain development: White Matter Volume | 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. | Birth to 22-24 months of age |
| Primary outcome related to brain development: Cortical Gray Matter Volume | 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. | Birth to 22-24 months of age |
| Primary outcome related to brain development: Deep Gray Matter Volume | 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. | Birth to 22-24 months of age |
| Primary outcome related to brain development: Lateral Ventricle Volume | 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. | Birth to 22-24 months of age |
| Primary outcome related to brain development: External cerebrospinal fluid | 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. | Birth to 22-24 months of age |
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Inclusion Criteria:
Exclusion Criteria:
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Infants will be prescreened at participating birth hospitals using the inclusion and exclusion criteria listed below.
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| Name | Affiliation | Role |
|---|---|---|
| Carla Bann, PhD | RTI International | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Children's National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40414418 | Derived | Merhar SL, Bann CM, Mack N, Newman JE, Limperopoulos C, Ambalavanan N, Davis JM, DeMauro SB, Lorch SA, Wilson-Costello DE, Peralta-Carcelan M, Parlberg LM, Poindexter BB, Kapse K, Kline-Fath BM, Murnick JG. Prenatal Opioid Exposure Is Associated with Punctate White Matter Lesions in Term Newborns. J Pediatr. 2025 Sep;284:114669. doi: 10.1016/j.jpeds.2025.114669. Epub 2025 May 23. | |
| 40193106 | Derived | Wu Y, Merhar SL, Bann CM, Newman JE, Kapse K, De Asis-Cruz J, Mack N, De Mauro SB, Ambalavanan N, Davis JM, Lorch SA, Wilson-Costello D, Poindexter BB, Peralta-Carcelen M, Limperopoulos C. Antenatal Opioid Exposure and Global and Regional Brain Volumes in Newborns. JAMA Pediatr. 2025 Jun 1;179(6):639-646. doi: 10.1001/jamapediatrics.2025.0277. |
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Plan to Share IPD
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| Primary outcome related to behavioral and development: Bayley Scales of Infant Development | 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. | 22-24 months of age |
| Primary outcome related to behavioral and development: Spot Vision Screener | 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. | 22-24 months of age |
| Primary outcome related to behavioral and development: BITSEA | 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. | 22-24 months of age |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| RTI International | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| Univeristy of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| 40186111 | Derived | Parlberg LM, Newman JE, Merhar SL, Poindexter B, DeMauro SB, Lorch SA, Peralta-Carcelen M, Wilson-Costello DE, Ambalavanan N, Limperopoulos C, Mack N, Davis JM, Walsh MC, Bann CM; ACT NOW OBOE Study Consortium. Risk factors for food insecurity and association with prenatal care utilization among women who took opioids during pregnancy and unexposed controls. BMC Pregnancy Childbirth. 2025 Apr 4;25(1):396. doi: 10.1186/s12884-025-07499-y. |
| 40057022 | Derived | Merhar SL, Yolton K, DeMauro SB, Beiersdorfer T, Newman JE, Lorch SA, Wilson-Costello D, Ambalavanan N, Bangdiwala A, Peralta-Carcelen M, Poindexter BB, Davis JM, Limperopoulos C, Bann CM. Neurobehavioral Profiles in Opioid-Exposed and Unexposed Neonates. J Pediatr. 2025 Jun;281:114527. doi: 10.1016/j.jpeds.2025.114527. Epub 2025 Mar 7. |
| 38585728 | Derived | Parlberg LM, Newman JE, Merhar S, Poindexter B, DeMauro S, Lorch S, Peralta-Carcelen M, Wilson-Costello D, Ambalavanan N, Limperopoulos C, Mack N, Davis JM, Walsh M, Bann CM. Risk factors for food insecurity and association with prenatal care utilization among women who took opioids during pregnancy. Res Sq [Preprint]. 2024 Mar 25:rs.3.rs-3921909. doi: 10.21203/rs.3.rs-3921909/v1. |