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

Neonatal Opioid Withdrawal Syndrome Clinical Trial

— OBOE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04149509
• Other study ID #: ACTNOW-03
• Secondary ID: 1PL1HD101059-01R
• Status: Recruiting
• Start date: August 19, 2020
• Est. completion date: July 2023

Study information

• Verified date: January 2023
• Source: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
• Contact: Carla Bann, PhD
• Phone: 919-485-2773
• Email: cmb[@]rti.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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).

Related Conditions & MeSH terms

• Neonatal Opioid Withdrawal Syndrome
• Substance Withdrawal Syndrome

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	RTI International	Durham	North Carolina
United States	Univeristy of Pennsylvania	Philadelphia	Pennsylvania
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome related to brain development: White Matter Volume	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.	Birth to 22-24 months of age
Primary	Primary outcome related to brain development: Cortical Gray Matter Volume	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.	Birth to 22-24 months of age
Primary	Primary outcome related to brain development: Deep Gray Matter Volume	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.	Birth to 22-24 months of age
Primary	Primary outcome related to brain development: Lateral Ventricle Volume	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.	Birth to 22-24 months of age
Primary	Primary outcome related to brain development: External cerebrospinal fluid	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.	Birth to 22-24 months of age
Primary	Primary outcome related to behavioral and development: Bayley Scales of Infant Development	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.	22-24 months of age
Primary	Primary outcome related to behavioral and development: Spot Vision Screener	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.	22-24 months of age
Primary	Primary outcome related to behavioral and development: BITSEA	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.	22-24 months of age