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Neonatal Abstinence Syndrome clinical trials

View clinical trials related to Neonatal Abstinence Syndrome.

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NCT ID: NCT04588519 Completed - Clinical trials for Neonatal Abstinence Syndrome

tAN to Mitigate Withdrawal Behaviors in Neonates

Start date: May 30, 2020
Phase: N/A
Study type: Interventional

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. Reducing Neonatal Opioid Withdrawal Syndrome (NOWS) symptoms may also help lessen or eliminate the need for opioid medication and shorten the length of the hospital stay. The neurostimulation device, currently called the Roo is a safe form of neurostimulation that uses sticker-like patches worn in and around the ear during the withdrawal period. The patches deliver a small and painless current of electrical pulses to the skin and underlying cranial nerves.

NCT ID: NCT04298853 Completed - Clinical trials for Neonatal Abstinence Syndrome

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Start date: June 30, 2020
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04049799 Completed - Opioid-use Disorder Clinical Trials

Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions

MOTHER DYAD
Start date: August 8, 2019
Phase:
Study type: Observational

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 neonatal outcomes. Outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. This study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.

NCT ID: NCT03973801 Completed - Clinical trials for Neonatal Abstinence Syndrome

Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)

Start date: August 19, 2019
Phase: N/A
Study type: Interventional

This study will assess the feasibility of implementing auricular acupressure as an additional non-pharmacologic therapy for neonates at risk for developing neonatal abstinence syndrome (NAS) at Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center (VUMC).

NCT ID: NCT03890562 Completed - Clinical trials for Neonatal Abstinence Syndrome

Assessing the Effects of Auricular Acupressure on Newborns With NAS

Start date: September 4, 2019
Phase: N/A
Study type: Interventional

This study will determine the feasibility of using auricular acupressure as an intervention in newborns with neonatal abstinence syndrome(NAS). Auricular acupuncture has been used as an intervention in adults in withdrawal by the National Acupuncture Detoxification Association with good results. The same points on the ear used by National Acupuncture Detoxification Association (NADA) will be used in this intervention using a spring-loaded microprobe to apply minimal pressure instead of needles. The purpose of this study is to identify barriers to recruiting newborns with NAS; to identify newborn behaviors during the intervention that determine tolerance of the intervention, and to compare results of vitals signs and withdrawal scores prior to intervention and post-intervention.

NCT ID: NCT03670160 Completed - Clinical trials for Neonatal Abstinence Syndrome

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).

NCT ID: NCT03608696 Completed - Clinical trials for Neonatal Abstinence Syndrome

Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

B-PHORE
Start date: August 29, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.

NCT ID: NCT03567603 Completed - Clinical trials for Neonatal Abstinence Syndrome

Sound Processing Changes in Babies With Opioid Exposure

Start date: March 25, 2019
Phase:
Study type: Observational

The purpose of this study is to identify problems with interpreting sounds in babies that have been exposed to opioids prior to birth. Being able to identify these issues in infancy may allow us to find children who may have problems with language learning later in life so that we can try to minimize these.

NCT ID: NCT03549936 Completed - Clinical trials for Neonatal Abstinence Syndrome

Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome

Start date: July 9, 2014
Phase: N/A
Study type: Interventional

Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS. This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.

NCT ID: NCT03334981 Completed - Clinical trials for Neonatal Abstinence Syndrome

Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome

SUBOPGEST
Start date: July 2012
Phase: N/A
Study type: Observational

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 syndrome (NAS). 43 women treated with buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.