Clinical trials: Neonatal Abstinence Syndrome
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
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, Neonatal Opioid Withdrawal
Improving Outcomes in Neonatal Abstinence Syndrome
1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied.
- Trial name
- NCT01958476
- Testing
- Neonatal Morphine Solution, Methadone, Phenobarbital
- Where
- 8 sites in United States
- Volunteers
- 117 people
- Sponsor
- Tufts Medical Center
Neonatal Abstinence Syndrome, Neonatal Withdrawal Syndrome
Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)
The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence Syndrome (NAS).
- Trial name
- NCT01708707
- Testing
- Buprenorphine, Morphine Sulfate
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Pediatrix
Opioid-use Disorder, Opioid Withdrawal
Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and…
- Conditions
- Opioid-use Disorder, Opioid Withdrawal, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome
- Trial name
- MOTHER DYAD (NCT04049799)
- Testing
- Medically-supervised withdrawal, Opioid agonist treatment, Comprehensive clinical care
- Where
- 4 sites in United States
- Volunteers
- 88 people
- Sponsor
- University of Vermont
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
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes.
- Trial name
- No-POPPY (NCT03396588)
- Testing
- Clonidine, Morphine
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Henrietta Bada
Opioid-use Disorder, Neonatal Abstinence Syndrome
MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study
This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder.
- Conditions
- Opioid-use Disorder, Neonatal Abstinence Syndrome, Pregnancy, High Risk, Alcohol Use Disorder
- Trial name
- NCT03718104
- Testing
- Pharmacokinetic analysis, Safety and Efficacy, Genetic and epigenetic analysis
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Boston Medical Center
Neonatal Abstinence Syndrome
The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
The chronic use of opiate medications during pregnancy is a major public health challenge. Prolonged exposure to opiates in utero may result in withdrawal symptoms in infants commonly referred to as neonatal abstinence syndrome…
- Trial name
- NCT01754324
- Testing
- Methadone
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Neonatal Abstinence Syndrome
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
- Trial name
- NCT04419857
- Testing
- High-calorie formula
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Yale University
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.
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and…
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs (NCT03918850)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 140 people
- Sponsor
- T. John Winhusen, PhD