Assessing microstructural and functional connectivity differences between infants with prenatal opioid exposure and opioid naive infants
Investigating Brain Magnetic Resonance Imaging (MRI) for Identifying Withdrawal Symptoms in Infants Exposed to Opioids
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: healthy
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Age: 100 years or below
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Gender: All
Inclusion Criteria
Group 1: (NAS+), Mother/infant dyads where infants require postnatal opioid therapy for NAS
Maternal Inclusion criteria
Age > 18yrs
History of maternal opioid misuse enrolled in prenatal opioid maintenance program in the antenatal clinic
Infant Inclusion criteria:
Born at > 36 weeks
Less than or equal to 48 weeks corrected gestational age at time of MRI
Develop NAS in the neonatal period requiring opioid medication therapy.
Group 2: (NAS-), Mother/infant dyads, where the infants do not require postnatal opioid therapy,
Maternal Inclusion criteria
Age > 18yrs
History of maternal opioid misuse enrolled in prenatal opioid maintenance program in the antenatal clinic
Infant Inclusion criteria:
Born at > 36 weeks
Less than or equal to 48 weeks corrected gestational age at time of MRI
Do not develop NAS in the neonatal period, or develop NAS in the neonatal period not requiring opioid medication therapy.
Group 3: (ON), Healthy opioid na?ve control mother/infants dyads
Maternal Inclusion criteria:
Age >18yrs
Healthy pregnancy carried to term
Infant Inclusion criteria:
Born at >36 weeks
Birth weight at least 2500g
Less than or equal to 48 weeks corrected gestational age at time of MRI
Exclusion Criteria
Group 1: (NAS+), Mother/infant dyads where infants require postnatal opioid therapy for NAS, n=10
Maternal Exclusion criteria
Reported prenatal alcohol use
Maternal health conditions including diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
Infant Exclusion criteria:
Presence of moderate or severe perinatal asphyxia as diagnosed clinically
History of congenital infection
History of medically diagnosed chorioamnionitis
Presence of any major congenital anomalies or genetic syndromes.
Group 2: (NAS-), Mother/infant dyads, where the infants do not require postnatal opioid therapy, n=10
Maternal Exclusion criteria
Reported prenatal alcohol use
Maternal health conditions including diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
Infant Exclusion criteria:
Presence of moderate or severe perinatal asphyxia as diagnosed by clinically
History of congenital infection
History of medically diagnosed chorioamnionitis
Presence of any major congenital anomalies or genetic syndromes.
Group 3: (ON), Healthy opioid na?ve control mother/infants dyads, n=10
Maternal Exclusion criteria:
Health conditions including diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
Use of any chronic medication during pregnancy other than prenatal vitamins
Any history of drug or substance use during pregnancy apart from prenatal vitamins
Infant Exclusion criteria:
Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment
NICU admission
Any significant birth complications, including the use of vacuum or forceps during delivery or emergent C-section
This study investigates whether MRI scans of the brain can identify infants who will experience withdrawal symptoms after being exposed to opioids before birth. The study aims to find differences in brain structure and function using MRI in infants who have been exposed to opioids compared to those who have not been exposed. Additionally, it seeks to identify differences in those exposed infants who require further opioid treatment after birth and those who do not.
Participants will undergo MRI procedures to assess brain differences. MRI, or Magnetic Resonance Imaging, is a test that uses magnets and radio waves to create pictures of organs and tissues inside the body. This study will compare the MRI results of infants with different levels of opioid exposure and treatment needs.
- Who can participate: Mothers aged over 18 years with a history of opioid misuse and their infants born after 36 weeks are eligible, provided the mothers are enrolled in a prenatal opioid maintenance program. Infants must be less than or equal to 48 weeks corrected gestational age at the time of MRI. Exclusion criteria include mothers and infants with significant medical complications or other drug dependencies. Healthy mothers with no drug use and their infants can also participate as controls.
- Study details: Participants will have MRI scans of their infants' brains to study differences related to opioid exposure. A placebo is not involved in this study.
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