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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149509
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : February 1, 2023
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

Study Description
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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

Condition or disease
Neonatal Opioid Withdrawal Syndrome

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023
Groups and Cohorts
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Group/Cohort
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Primary outcome related to brain development: White Matter Volume [ Time Frame: 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.

  2. Primary outcome related to brain development: Cortical Gray Matter Volume [ Time Frame: 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.

  3. Primary outcome related to brain development: Deep Gray Matter Volume [ Time Frame: 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.

  4. Primary outcome related to brain development: Lateral Ventricle Volume [ Time Frame: 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.

  5. Primary outcome related to brain development: External cerebrospinal fluid [ Time Frame: 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.

  6. Primary outcome related to behavioral and development: Bayley Scales of Infant Development [ Time Frame: 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.

  7. Primary outcome related to behavioral and development: Spot Vision Screener [ Time Frame: 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.

  8. Primary outcome related to behavioral and development: BITSEA [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants will be prescreened at participating birth hospitals using the inclusion and exclusion criteria listed below.
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149509


Contacts
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Contact: Carla Bann, PhD 919-485-2773 cmb@rti.org
Contact: Jamie Newman, PhD 9194855719

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Namasivayam Ambalavanan, MD         
Sub-Investigator: Myriam Peralta-Carcelen, MD         
United States, District of Columbia
Children's National Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, North Carolina
RTI International Active, not recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Stephanie Merhar, MD         
Sub-Investigator: Brenda Poindexter, MD         
Case Western Reserve University, Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Dee Wilson, MD         
United States, Pennsylvania
Univeristy of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sara DeMauro, MD         
Sub-Investigator: Scott Lorch, MD         
Sponsors and Collaborators
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Director: Carla Bann, PhD RTI International
More Information
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Responsible Party: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
ClinicalTrials.gov Identifier: NCT04149509    
Other Study ID Numbers: ACTNOW-03
1PL1HD101059-01 ( U.S. NIH Grant/Contract )
RL1HD104251 ( U.S. NIH Grant/Contract )
RL1HD104252 ( U.S. NIH Grant/Contract )
RL1HD104253 ( U.S. NIH Grant/Contract )
RL1HD104254 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to Share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program:
NOWS
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders