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Showing 1-13 of 13 trials
NCT04783558
Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies while they are pregnant, yet, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial.
NCT05129020
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
NCT04419857
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.
NCT04508348
A clinical trial to evaluate length of stay, growth velocity and clinical outcomes in infants with neonatal abstinence syndrome receiving an exclusive human milk diet. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier.
NCT03725332
Perinatal opioid use disorder (OUD) is a major health concern in the U.S. with significant impact on mothers, infants, and communities. Investigators at the University of Kentucky/UK HealthCare (UK) have developed a comprehensive clinical care model for perinatal OUD (known as UK-PATHways) that has demonstrated success in maternal and neonatal outcomes. The overreaching goals of the proposed project are to: 1) expand the reach of this successful clinical program to rural communities thereby improving access to integrated MAT prenatal care, 2) to reduce the impact of perinatal OUD in underserved rural areas of our state, and 3) to compare the relative effectiveness methods of delivery active elements of the UK-PATHways program for rural implementation (local group-support vs. telemedicine).
NCT04298853
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.
NCT04983563
The aim of this study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome of hospitalized newborn in intensive care units
NCT02872077
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. The investigators will evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay. This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.
NCT03334981
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.
NCT01734551
The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.
NCT00496951
Symptoms of Neonatal Abstinence Syndrome (NAS) can be attributed largely to dysfunction of the autonomic nervous system in opiate exposed neonates. Vagal tone is a readily available measure of autonomic nervous system functioning. NAS is a widely variable disorder with poorly understood pathophysiology; while all opiate exposed infants will exhibit some signs and symptoms of NAS, only approximately ½ have severe enough symptoms to require pharmacologic therapy. This research seeks to determine the relationship between infant vagal tone and NAS severity. The determination of a link between newborn vagal tone and NAS severity could result in the prediction of infants at risk for severe NAS and provide these infants and mothers with intensified services and early treatment, thereby shortening the course of NAS in the infant.
NCT00521248
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. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").
NCT02797990
Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.