Active clinical trials for "Neonatal Abstinence Syndrome"

Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.

The primary objective of this study is to test the efficacy of a Motivational Interviewing and Educational Training intervention with immediate linkage to long acting reversible contraception (LARC) (hereafter known as MIET). MIET will be delivered to women of childbearing age (18-44) through the Meharry Addiction Clinic to women residing in Nashville, Tennessee. There are two aims associated with this study. The primary aim is to determine the efficacy of MIET, to promote insertion of LARC among young, urban dwelling, low income women living with OUD and at-risk of unplanned pregnancy. The primary endpoint of this aim are: 1) meeting with a provider regarding initial assessment for LARC, 2) having a LARC implant. Because of potential contraindication for LARC insertion (i.e. obesity) the first endpoint of meeting with a LARC provider is most proximal to aim 1. However, determining the number of willing women that go on to receive the implant is also critical in that it reflects potential decreases in cost to the health care system through reduction of unintended pregnancy and related subsequent NAS in the newborn. The second aim for the study is to utilize qualitative and quantitative data collected for the study to modify the MIET intervention to more effectively meet the needs of the women in the study. Survey data for the study will be collected at baseline, one and six months. Of note, the baseline, one and six month survey data collections will provide potential co-variates to consider in analysis of aim one and two. The primary endpoints however will come from the six month records review. We will gain consent to access records at the baseline consent, and will gather these data from the Meharry Electronic Health Record.

In this retrospective cohort study, we plan to examine the relationship between buprenorphine dose adjustments, gestational age, urine buprenorphine levels and the rate of neonatal abstinence syndrome in opioid-maintained pregnant women

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 (NAS). Signs of NAS may include irritability, high-pitched crying, muscle tightness, seizures, diarrhea, vomiting, poor feeding, and unstable body temperature. Many infants may be treated by supportive (non-pharmacological) therapy by minimizing stimulation, cuddling, responding promptly to hunger cues, and other comfort care. However, some infants continue to show severe symptoms of withdrawal despite these interventions. In these cases, infants may be treated with medications (pharmacological therapy). Although it has been several decades since the first descriptions of NAS, there still remains limited information with regards to the most effective treatment. We hypothesize that medical treatment protocols of NAS with methadone can be optimized by better understanding what the body does to the drug (the population-based pharmacokinetics of methadone).

This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS. Specifically, gastrointestinal (GI) sub-scores, as well as total scores, will be compared between infants historically fed formula and those enrolled in a 2-week donor human milk study period. Purpose of study: to test the following null hypothesis: Infants with a diagnosis of neonatal abstinence syndrome (NAS) due to in-utero exposure to opiates, fed donor human milk, will have similar GI/feeding sub-scores of the Finnegan scoring tool when compared to (historic) infants fed formula. A rejection of the null hypothesis will be used to design a randomized trial of donor human milk in infants with NAS.

The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury.

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.

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.

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. Our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with regards to the outcome of pregnancy.

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.