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Active clinical trials for "Neonatal Abstinence Syndrome"

Results 31-40 of 62

RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants

Neonatal Abstinence Syndrome

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 for these high-risk infants. We will conduct a preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and estimates of whether high-calorie formula results in more normal patterns of weight loss and gain, less severe NAS symptoms and shorter hospital stays.

Completed9 enrollment criteria

Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome

The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids in utero.

Completed12 enrollment criteria

Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

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).

Completed12 enrollment criteria

Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome

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. Half of infants who require pharmacotherapy for NAS will receive a methadone wean, and half will receive a morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be studied.

Completed8 enrollment criteria

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

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. 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").

Completed11 enrollment criteria

Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

Neonatal Abstinence SyndromeNeonatal Opiate Withdrawal Syndrome

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.

Completed8 enrollment criteria

Improving Outcomes in Neonatal Abstinence Syndrome

Neonatal Abstinence SyndromeNeonatal Opioid Withdrawal

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. Infants will be randomized to receive either morphine or methadone. It is hypothesized that morphine treated infants will do better and require fewer days in the hospital compared to methadone treated infants. 2. SPECIFIC Aim II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants will be evaluated with development testing at 18 months of age. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will correlate with neurodevelopmental impairment at 18 months. 3: SPECIFIC Aim III: To determine if common genetic variations in the genes involving narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all infants and analyzed for differences in 3 key genes. This will then be correlated with short-term and long-term outcomes.

Completed14 enrollment criteria

Treatment of Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome

This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.

Completed12 enrollment criteria

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

Opioid-use DisorderOpioid Withdrawal2 more

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.

Active4 enrollment criteria

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome

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).

Completed6 enrollment criteria
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