The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).
One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.
Study Type
OBSERVATIONAL
Enrollment
600
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.
Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGIncidence of opioid misuse severity using assessments
Incidence of opioid misuse severity and buprenorphine treatment response will be assessed by the treating physician using assessments such as Who Assist, TCU Motform, Adverse Childhood Experience Assessment, Ham-A and Ham-D.
Time frame: 5 years
Pharmacological treatment for neonatal abstinence syndrome
Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
Time frame: 5 years
Incidence of adverse effects of buprenorphine using MRI
Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.
Time frame: 5 years
Concentration of long-term neurodevelopmental outcomes using assessments
Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.
Time frame: 5 years
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