# Clinical markers of neonatal opioid withdrawal syndrome: onset, severity and longitudinal neurodevelopmental outcome

> **NIH NIH R01** · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · 2021 · $778,715

## Abstract

ABSTRACT
Every 20 minutes in the United States, a newborn is born exposed to opioids. Approximately 50-80% of these
newborns will develop Neonatal Opioid Withdrawal Syndrome (NOWS), characterized by autonomic instability,
hyperactivity, irritability, tremors, abnormal cry, and difficulty feeding and sleeping. Standard of care dictates
that these newborns should be placed on a 96-hour “hold” in the hospital for observation of NOWS. However,
this prolonged hospital stay can lead to both pharmacological and nonpharmacological treatment and even
longer hospitalization. For newborns that do develop NOWS, evidence suggests that non-pharmacological
interventions could reduce the symptoms of NOWS if intervention is implemented before symptoms of NOWS
are detected. The goal of this proposal is to test four novel, noninvasive clinical predictors of NOWS in
newborns and as markers of neurodevelopmental impairment at 6 and 18 months: Newborn neurobehavioral
assessments, newborn cry, prenatal substance exposure measured via maternal hair, and adverse
socioeconomic environments. We correctly identified 86.1% of newborns diagnosed with NOWS using our
NNNS and cry data in our pilot studies. If replicated, these findings could lead to personalized treatment
regimens and improved care for newborns. The identification of these factors could also provide insights into
the pathophysiology and clinical presentation of NOWS. We will conduct longitudinal neurodevelopmental
assessments at 6 and 18 months to determine whether these markers predict developmental impairment at
these ages. We will also examine whether a diagnosis of NOWS predicts neurodevelopmental impairment at 6
and 18 months. These data will provide clinicians and caregivers with valuable information about the extent to
which a NOWS diagnosis portends difficulties in cognitive, motor, or language development in infancy and
toddlerhood. We will enroll 312 newborns and their caregivers across two sites: Women and Infants Hospital of
Rhode Island and the University of Utah Hospital. Both sites have begun collecting pilot data and have
demonstrated success in recruiting 8 newborns/month. The MPIs have an almost 10-year history of
collaboration and have published over 20 articles together. In both sites they have established high recruitment
and retention rates. The scientific aims of this study are complimented and informed by a carefully designed
recruitment and retention plan, and protection of human subjects protocol intended to minimize risk to all
participants and provide appropriate resources to caregivers and newborns. When our aims are realized, we
will have generated novel and objective predictors of NOWS onset and severity, as well as
neurodevelopmental impairment at 6 and 18 months. This longitudinal study will establish a cohort of newborns
with prenatal opioid exposure that we plan to retain for long-term neurodevelopmental follow-up into childhood.
We also address one of the most pressing societ...

## Key facts

- **NIH application ID:** 10122943
- **Project number:** 5R01DA049755-02
- **Recipient organization:** WOMEN AND INFANTS HOSPITAL-RHODE ISLAND
- **Principal Investigator:** Liz D Conradt
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $778,715
- **Award type:** 5
- **Project period:** 2020-04-01 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10122943

## Citation

> US National Institutes of Health, RePORTER application 10122943, Clinical markers of neonatal opioid withdrawal syndrome: onset, severity and longitudinal neurodevelopmental outcome (5R01DA049755-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10122943. Licensed CC0.

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