Clinical trials: Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
The purpose of this study is to show non-inferiority between two medications used for medical treatment of withdrawal seen in Neonatal Abstinence Syndrome (NAS), Clonidine and Morphine Sulfate (used in routine care) on length of…
- Trial name
- NCT03092011
- Testing
- Clonidine, Morphine Sulfate
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- The Cooper Health System
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
Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome
This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General Hospital NICU.
- Trial name
- AA NAS (NCT02872077)
- Testing
- Auricular acupuncture
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of South Florida
Neonatal Abstinence Syndrome
The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Perinatal opioid use disorder (OUD) is a major health concern in the U.S. with significant impact on mothers, infants, and communities.
- Trial name
- PATH (NCT03725332)
- Testing
- Telemedicine, Group Care
- Where
- 11 sites in United States
- Volunteers
- 269 people
- Sponsor
- Wendy F Hansen
Substance Addiction
Maternal Acupuncture for Substance Abuse
To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women..
- Trial name
- NCT00225316
- Testing
- Acupuncture
- Where
- Canada
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Neonatal Abstinence Syndrome
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS).
- Trial name
- NCT06303986
- Testing
- NeoMonki
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rekovar Inc.
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
Neonatal Abstinence Syndrome
Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
The overall purpose of this project is to to quantify the physiology of neonatal drug withdrawal and develop non-pharmacological techniques to help improve the therapeutic management of Neonatal Abstinence Syndrome (NAS).
- Trial name
- NCT02768844
- Testing
- Stochastic Vibrotactile Stimulation (SVS), Control
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Massachusetts, Worcester
Neonatal Abstinence Syndrome
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero.
- Trial name
- NCT02851303
- Testing
- Morphine, Methadone
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of New Mexico
Neonatal Abstinence Syndrome, Opioid-use Disorder
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn.
- Trial name
- NCT04783558
- Testing
- Mobile-based NAS Caregiving Tool
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Washington State University
Neonatal Abstinence Syndrome
Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers
Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant.
- Trial name
- HOPE (NCT01889121)
- Testing
- Structured psychosocial intervention
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Dr. Henry Akinbi
Neonatal Abstinence Syndrome
Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium.
- Trial name
- NCT00521248
- Testing
- buprenorphine, Oral morphine solution
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Thomas Jefferson University
Neonatal Abstinence Syndrome
Clonidine for Neonatal Abstinence Syndrome Study
The study plans to compare the use of Clonidine versus Phenobarbital as an additional medication to neonatal morphine sulfate for treatment of newborn infants undergoing drug withdrawal symptoms due to mother's use of opioid drug…
- Trial name
- NCT01175668
- Testing
- Clonidine, Phenobarbital
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Baystate Medical Center
Neonatal Abstinence Syndrome
RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants
Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes…
- Trial name
- NCT02178189
- Testing
- High Calorie Infant formula, Standard Calorie Infant Formula
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- University of Pittsburgh
Neonatal Abstinence Syndrome
Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome
The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence…
- Trial name
- SUBOPGEST (NCT03334981)
- Testing
- Concentrations in Meconium of Buprenorphine and Methadone
- Where
- France
- Volunteers
- 92 people
- Sponsor
- University Hospital, Caen
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
- Conditions
- Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
- Trial name
- NCT04298853
- Testing
- Morphine PRN, Morphine scheduled
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indiana University
Opioid Use Disorder, Neonatal Abstinence Syndrome
RESPECT-PLUS: Services for Infants With Prenatal Opiate Exposure
The impact of parental opioid use disorder and other substance use exposure on child welfare and the healthcare system is undeniable.
- Conditions
- Opioid Use Disorder, Neonatal Abstinence Syndrome, Child Development, Child Abuse
- Trial name
- RESPECT-Plus (NCT02334111)
- Testing
- RESPECT-Plus
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Medical Center
Neonatal Abstinence Syndrome
Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
- Trial name
- NAS (NCT00510016)
- Testing
- Clonidine HCL
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid Use Disorder, Neonatal Abstinence Syndrome
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD…
- Trial name
- SUPPORT (NCT06576323)
- Testing
- An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
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.