Neonatal Opioid Withdrawal Syndrome

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Review clinical trials related to Neonatal Opioid Withdrawal Syndrome. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Cerebral Physiology of NOWS

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.

Participants needed: 46
Trial details
Age: Up to 1Biological sex: AllType: InterventionalSponsor: Indiana UniversityUpdated: Aug 19, 2026Locations: 1
Eligibility criteria

Term born or near-term born (> 36w) infants [+7]

APGAR score at 5 min < 7 [+9]

Status: Recruiting

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are: 1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine? 2. Does one treatment lead to better overall clinical outcomes than the other? Researchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly. Participants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care. No new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.

Participants needed: 796
Trial details
Age: 0+Biological sex: AllType: ObservationalSponsor: HELP for NOWS ConsortiumUpdated: Feb 25, 2026Locations: 22Duration: 90 Days
Eligibility criteria

Infant is ≥ 36 weeks' gestational age [+7]

Infant has major congenital anomalies. [+5]

Status: Recruiting

MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this increasingly common medical condition. The proposed study will define the molecular mechanisms that regulate the response to opioid withdrawal in the developing brain by focusing on three candidate microRNAs (let-7a, miR-146a, miR-192) that have been shown to respond to opioid exposure in animal models and adults, and are impacted in both my preliminary study of infants with NAS, and my human neural progenitor cell (NPC) design of opioid withdrawal. By determining the mechanism through which microRNAs impact NPC differentiation in opioid withdrawal, and determining whether exosomal salivary microRNA levels predict treatment dose and neurodevelopmental outcomes in infants with NAS, this study will enhance our knowledge of NAS-related biology and identify potential biomarkers that could improve medical care for this important medical condition.

Participants needed: 50
Trial details
Age: 1-5Biological sex: AllType: ObservationalSponsor: Milton S. Hershey Medical CenterUpdated: Feb 10, 2026Locations: 1
Eligibility criteria

Newborns ≥35weeks gestation with chronic in-utero opioid exposure (>1month of ge... [+2]

<35 week gestation [+6]