Active — Not RecruitingNot Applicable

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

United States300 participantsStarted 2020-08-19

Plain-language 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

Who can participate

Age range

1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary outcome related to brain development: White Matter Volume

Timeframe: Birth to 22-24 months of age

Primary outcome related to brain development: Cortical Gray Matter Volume

Timeframe: Birth to 22-24 months of age

Primary outcome related to brain development: Deep Gray Matter Volume

Timeframe: Birth to 22-24 months of age

Primary outcome related to brain development: Lateral Ventricle Volume

Timeframe: Birth to 22-24 months of age

Primary outcome related to brain development: External cerebrospinal fluid

Timeframe: Birth to 22-24 months of age

Primary outcome related to behavioral and development: Bayley Scales of Infant Development

Timeframe: 22-24 months of age

Primary outcome related to behavioral and development: Spot Vision Screener

Timeframe: 22-24 months of age

Trial details

NCT IDNCT04149509

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

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Neonatal Opioid Withdrawal Syndrome trials

Plain-language summary

Who can participate

Age range

1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

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

What they're measuring

Primary outcome related to brain development: White Matter Volume

Timeframe: Birth to 22-24 months of age

Primary outcome related to brain development: Cortical Gray Matter Volume

Timeframe: Birth to 22-24 months of age

Primary outcome related to brain development: Deep Gray Matter Volume

Timeframe: Birth to 22-24 months of age

Primary outcome related to brain development: Lateral Ventricle Volume

Timeframe: Birth to 22-24 months of age

Primary outcome related to brain development: External cerebrospinal fluid

Timeframe: Birth to 22-24 months of age

Primary outcome related to behavioral and development: Bayley Scales of Infant Development

Timeframe: 22-24 months of age

Primary outcome related to behavioral and development: Spot Vision Screener

Timeframe: 22-24 months of age