Assessing microstructural and functional connectivity differences between infants with prenatal opioid exposure and opioid naive infants

Recruiting
100 years or below
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to find whether MRI of the brain can help in identifying infants who will have withdrawal symptoms after prenatal exposure to opioids.

Detailed description of study

Aim 1: Identify microstructural and functional MRI differences in infants with prenatal opioid exposure compared to opioid na?ve infants. Aim 2: Identify microstructural and functional MRI differences in infants with prenatal opioid exposure that require postnatal opioid treatment compared to those that do not require postnatal opioid treatment.
Participants will be compensated for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: healthy
  • Age: 100 years or below
  • 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

Updated on 04 Aug 2024. Study ID: 1805434720

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