Predicting neurodevelopmental outcomes in neonatal abstinence syndrome

R
Rupa Radhakrishnan, MD

Primary Investigator

Overview

The purpose of this study is to find whether an MRI of the brain can help identify which infants will have withdrawal symptoms after having been exposed to opioids prenatally.

Description

The purpose of this study is to identify early functional MRI differences in infants with NAS compared to healthy controls; and to identify associations between brain functional connectivity in infants with NAS and neurodevelopmental outcomes at 6 months.

Eligibility

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

  • Conditions:
    neonatal abstinence syndrome
  • Age: - 100 Years
  • Gender: All

Inclusion Criteria
Infants with NAS:
Born at > 36 weeks
Less than or equal to 48 weeks corrected gestational age at time of MRI
History of maternal opioid use with prenatal opioid maintenance treatment enrolled in the antenatal clinic
No reported prenatal alcohol exposure
Prenatal opioid exposure requiring pharmacologic treatment.
Mothers of infants with NAS:
Age > 18yrs
History of maternal opioid misuse enrolled in prenatal opioid maintenance program in the antenatal clinic
Healthy control infants:
Born at >36 weeks
Birth weight at least 2500g
Less than or equal to 48 weeks corrected gestational age at time of MRI
Mothers of healthy control infants:
Age >18yrs
Healthy pregnancy carried to term
Exclusion Criteria
Infants with NAS:
History of moderate or severe perinatal asphyxia diagnosed clinically.
2 History of medically diagnosed chorioamnionitis
3 Major congenital anomalies or genetic syndromes affecting neurodevelopment
Mothers of infants with NAS:
Reported alcohol use during pregnancy
Maternal health conditions including diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
Healthy control infants:
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
Mothers of healthy control infants:
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


Additional Information:
Participants will be compensated for their participation.

Updated on 18 Apr 2024. Study ID: 1805384405

Interested in the study?

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