Clinical trial NCT04149509: ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
Official title: ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neonatal Opioid Withdrawal Syndrome
Keywords: NOWS
Lead sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Sponsor class: NETWORK
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-11-04
Enrollment: 300
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants will be prescreened at participating birth hospitals using the inclusion and exclusion criteria listed below.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Primary outcome related to brain development: White Matter Volume
timeFrame: Birth to 22-24 months of age
measure: Primary outcome related to brain development: Cortical Gray Matter Volume
timeFrame: Birth to 22-24 months of age
measure: Primary outcome related to brain development: Deep Gray Matter Volume
timeFrame: Birth to 22-24 months of age
measure: Primary outcome related to brain development: Lateral Ventricle Volume
timeFrame: Birth to 22-24 months of age
measure: Primary outcome related to brain development: External cerebrospinal fluid
timeFrame: Birth to 22-24 months of age
measure: Primary outcome related to behavioral and development: Bayley Scales of Infant Development
timeFrame: 22-24 months of age
measure: Primary outcome related to behavioral and development: Spot Vision Screener
timeFrame: 22-24 months of age
measure: Primary outcome related to behavioral and development: BITSEA
timeFrame: 22-24 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Washington, D.C.
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Durham
country: United States
facility: RTI International
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Univeristy of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: RTI International
name: Carla Bann, PhD
role: STUDY_DIRECTOR
References: