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

Conditions

Neonatal Opioid Withdrawal Syndrome

Keywords

NOWS

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

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.

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.

2025-06-011 citations

10.1001/jamapediatrics.2025.0277

Prenatal Opioid Exposure Is Associated with Punctate White Matter Lesions in Term Newborns.

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.

2025-05-23

10.1016/j.jpeds.2025.114669

Risk factors for food insecurity and association with prenatal care utilization among women who took opioids during pregnancy and unexposed controls.

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.

2025-04-04

10.1186/s12884-025-07499-y

Neurobehavioral Profiles in Opioid-Exposed and Unexposed Neonates.

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.

2025-03-07

10.1016/j.jpeds.2025.114527

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

Yes

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

1. Infants with known chromosomal or congenital anomalies potentially affecting the central nervous system 2. Apgar score at 5 minutes of \<5 3. Any requirement for positive pressure ventilation in the NICU 4. Inability to return for outpatient MRI and/or follow-up 5. IUGR \<3rd percentile 6. Heavy alcohol use during pregnancy (8+ drinks per week).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results