Clinical trials: Neonatal Opioid Withdrawal
Opioid Withdrawal (Disorder)
Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
A randomized, open-label, controlled, ascending dose cohort, PK, and safety study assessing standard of care (i.e., non-pharmacologic measures and morphine when indicated) with or without lofexidine for the treatment of opioid…
- Trial name
- NCT06047834
- Testing
- Standard of Care with Lofexidine, Standard of Care without Lofexidine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- BioCorRx Pharmaceuticals Inc
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Neonatal Opiate Withdrawal Syndrome
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS.
- Trial name
- OPTimize NOW (NCT05980260)
- Testing
- Symptom-based Dosing Approach, Scheduled Opioid Taper Approach
- Where
- 23 sites in United States
- Volunteers
- 626 people
- Sponsor
- HELP for NOWS Consortium
Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
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.
- Conditions
- Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure
- Trial name
- NIRS for NOWS (NCT07610746)
- Testing
- FD-NIRS and DCS
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Indiana University
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
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…
- Trial name
- NCT05937594
- Testing
- Buccal swab saliva for further genetic testing
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Milton S. Hershey Medical Center
Neonatal Opioid Withdrawal Syndrome
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).
- Trial name
- TreaT NOW (NCT07278375)
- Where
- 22 sites in United States
- Volunteers
- 796 people
- Sponsor
- HELP for NOWS Consortium
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal opioid withdrawal syndrome (NOWS) can affect a newborn infant's ability to eat, sleep, and be consoled after exposure to opioids before birth.
- Conditions
- Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure, Opioid Withdrawal, Neonatal Abstinence Syndrome
- Trial name
- VOICE-NAS (NCT07864493)
- Testing
- Recorded Parent/Caregiver Voice Playback
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- University of Manitoba
Neonatal Abstinence Syndrome
How to Treat Opiate Withdrawal in Neonates
Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score.
- Trial name
- NCT02810782
- Testing
- Phenobarbital, Chlorpromazine, Morphine
- Volunteers
- 120 people
- Sponsor
- University of Zurich
Neonatal Opioid Withdrawal Syndrome
Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS)
This randomized control trial will compare buprenorphine and morphine, two currently used medications for the treatment of neonatal opioid withdrawal syndrome (NOWS), in newborns to determine which medication will reduce the…
- Trial name
- NCT04455802
- Where
- United States
- Sponsor
- Women and Infants Hospital of Rhode Island