ACT NOW Longitudinal Study: Outcomes of Babies with Opioid Exposure Study (OBOE)

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

Status: Active, not recruiting

Conditions: Neonatal Opioid Withdrawal Syndrome

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT04149509

1PL1HD101059-01 (U.S. NIH Grant/Contract)

RL1HD104253 (U.S. NIH Grant/Contract)

RL1HD104251 (U.S. NIH Grant/Contract)

RL1HD104252 (U.S. NIH Grant/Contract)

RL1HD104254 (U.S. NIH Grant/Contract)

ACTNOW-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: Under 1 month old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

300 participants in 2 patient groups

Exposed

Description:

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

Description:

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.