This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.
Term born or near-term born (> 36w) infants
Birth weight > 2 Kg
History of prenatal opioid exposure
Term born or near-term born (> 36w) infants
APGAR score at 5 min < 7
Any major congenital malformations or genetic syndromes
Need for positive pressure ventilation in the delivery room
APGAR score at 5 min < 7
Parallel
FD-NIRS and DCS
DeviceThe investigators will use a novel optical-based device that combines two advanced NIRS techniques, frequency-domain NIRS (FD-NIRS) and diffuse correlation spectroscopy (DCS), to quantify regional cerebral oxygenation (SO2), cerebral blood flow (CBF) and cerebral oxygen consumption (CMRO2).
Daily measurements of cerebral oxygenation
For aims 1 and 2, daily measurements of cerebral oxygenation (%) will be obtained using the bedside optical device in infants with POE and age-matched controls during the first five days after birth. For aim 3, longitudinal measurements of cerebral oxygenation (%) will be obtained using the bedside optical device in infants with severe NOWS undergoing pharmacological treatment.
Daily measurements of cerebral blood flow
For aims 1 and 2, daily measurements of cerebral blood flow (cm\^2/s) will be obtained using the bedside optical device in infants with POE and age-matched controls during the first five days after birth. For aim 3, longitudinal measurements of cerebral blood flow (cm\^2/s) will be obtained using the bedside optical device in infants with severe NOWS undergoing pharmacological treatment.
Daily measurements of cerebral oxygen consumption
For aims 1 and 2, daily measurements of cerebral oxygen consumption (mol/dl.cm\^2/s) will be obtained using the bedside optical device in infants with POE and age-matched controls during the first five days after birth. For aim 3, longitudinal measurements of cerebral oxygen consumption (mol/dl.cm\^2/s) will be obtained using the bedside optical device in infants with severe NOWS undergoing pharmacological treatment.
Severity of neonatal opioid withdrawal
The numerical modified Finnegan score (FNAST) or the Eat, Sleep, Console (ESC) score, depending on which tool is used for scoring at the site, will be recorded closest in proximity to measurements of cerebral physiology. The FNAST is a long-standing scoring tool that gives a numerical score as a measure of severity of withdrawal, with higher scores being more severe, up to a maximum of 24. The ESC score is a newer scoring tool that is not numerical but rather normal or abnormal in 3 categories of symptoms. Having an abnormal score for any of the 3 categories may qualify for intervention.
Length of hospital stay
Length of hospital stay in days.
Need for postnatal pharmacologic treatment
Whether the infant requires pharmacologic treatment with an opioid to treat severe neonatal opioid withdrawal.
Total postnatal opioid exposure
Total cumulative amount of morphine needed to treat neonatal opioid withdrawal in mg/kg (based on birth weight)
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Indiana University
Lead sponsor
Indiana Clinical and Translational Sciences Institute
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
