Vital Signs In Opioid-Exposed Neonates

Project Summary
Rates of opioid use during pregnancy are at epidemic proportions. Infants exposed to opioids before
birth frequently develop neonatal opioid withdrawal syndrome (NOWS) and are at a much higher risk of
sudden infant death syndrome (SIDS). A major knowledge gap is that it not currently possible to determine
the magnitude of NOWS or SIDS risk in opioid-exposed infants. Most infants with antenatal opioid exposure
are observed for several days after birth in the hospital to determine if the infant develops NOWS. Infants who
develop NOWS are frequently managed using the Finnegan scoring system which is complex and subjective.
There is therefore a need for rapid objective and quantitative measurement of signs of opioid withdrawal.
There is a critical need to determine if the hospital course of NOWS or abnormalities in respiratory control can
be predicted soon after birth, in order to initiate earlier monitoring or therapy. Furthermore, it is essential to be
able to adjust therapy in a more evidence-based manner.
The overall objective of the Vital Signs In Opioid-exposed Neonates (ViSION) project is to use
cardiorespiratory dynamics (characteristics and patterns of heart rate, respiratory rate, and oxygen saturations)
soon after birth from the existing large cohort of opioid-exposed newborns (>140/yr) at the University of
Alabama at Birmingham to develop and validate mathematical models to predict (a) onset of NOWS, (b)
changes in magnitude of NOWS as estimated by Finnegan scoring, and (c) abnormal polysomnographic
(sleep) study at three months of age. The central hypothesis of this proposed study is that cardiorespiratory
dynamics improve detection of NOWS onset and severity, and can predict infants with sleep disordered
breathing before discharge. The Specific Aims are:
Specific Aim 1: Test the hypothesis that cardiorespiratory dynamics soon after birth identify opioid-exposed
neonates at higher risk of neonatal opioid withdrawal syndrome. This hypothesis will be tested in a
prospective cohort of 200 opioid-exposed newborn infants and 100 healthy control infants.
Specific Aim 2: Test the hypothesis that cardiorespiratory dynamics of infants diagnosed with neonatal
opioid withdrawal syndrome track temporally with clinical assessment by the Finnegan scoring. This
hypothesis will be tested in a prospective cohort of 100 newborn infants diagnosed with neonatal opioid
withdrawal syndrome.
Specific Aim 3: Test the hypothesis that intermittent hypoxemia and bradycardia events soon after birth are
associated with apnea-hypopnea index on polysomnographic studies at three months of age. This hypothesis
will be tested in a prospective cohort of 60 newborn infants diagnosed with NOWS, 60 opioid-exposed infants
without NOWS, and 60 healthy control infants.

Grant Number: 5R01HD105205-05
NIH Institute/Center: NIH
Principal Investigator: Namasivayam Ambalavanan