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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-19

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Neonatal Opioid Withdrawal Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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).

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carla Bann, PhD

Role: STUDY_DIRECTOR

RTI International

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

RTI International

Durham, North Carolina, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

Univeristy of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 40414418 (View on PubMed)

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.

Reference Type DERIVED

PMID: 40193106 (View on PubMed)

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.

Reference Type DERIVED

PMID: 40186111 (View on PubMed)

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.

Reference Type DERIVED

PMID: 40057022 (View on PubMed)

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.

Reference Type DERIVED

PMID: 38585728 (View on PubMed)