diazepam and Neonatal Abstinence Syndrome

diazepam has been researched along with Neonatal Abstinence Syndrome in 13 studies

Diazepam: A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of GAMMA-AMINOBUTYRIC ACID activity.
diazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a chloro group at position 7, a methyl group at position 1 and a phenyl group at position 5.

Neonatal Abstinence Syndrome: Fetal and neonatal addiction and withdrawal as a result of the mother's dependence on drugs during pregnancy. Withdrawal or abstinence symptoms develop shortly after birth. Symptoms exhibited are loud, high-pitched crying, sweating, yawning and gastrointestinal disturbances.

Research

Studies (13)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Breastfeeding Initiation and Continuation at Hospital Discharge

Assessed through chart review of discharge summary documentation of method of infant feeding at time of discharge (NCT02851303)
Timeframe: assessed at hospital discharge, approximately 7-30 days

Length of Hospital Stay

Number of days in hospital after birth (NCT02851303)
Timeframe: assessed at hospital discharge, approximately 7-30 days

Length of Treatment

(NCT02851303)
Timeframe: assessed at hospital discharge, approximately 7-30 days

Need for Additional Agent to Treat Withdrawal, Determined by Chart Review of Medication Administration Record of Administered Medications for Withdrawal Treatment (Example: Clonidine or Phenobarbital)

clonidine (NCT02851303)
Timeframe: assessed at hospital discharge, approximately 7-30 days

Need for Feeding Assistance, Determined by Chart Review of Discharge Summary, Specifically Evaluating for Need for Nasogastric Tube Placement or Peripheral Parenteral Nutrition.

(NCT02851303)
Timeframe: assessed at hospital discharge, approximately 7-30 days

Need for NICU Transfer, as Determined by Chart Review of Discharge Summary.

(NCT02851303)
Timeframe: assessed at hospital discharge, approximately 7-30 days

Total Morphine Equivalent Dose Received

(NCT02851303)
Timeframe: assessed at hospital discharge, approximately 7-30 days

Duration of Treatment

Total number days of treatment (NCT01734551)
Timeframe: 120 days

Bayley Scales of Infant and Toddler Development Third Edition

Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15. Scores below 1 standard deviation (= or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain The score for each domain (motor, cognitive, and language functioning) represents the full-scale score (NCT01734551)
Timeframe: 1 year of life

Finnegan Neonatal Abstinence Scoring System

Mean of total Finnegan Scores obtained every 3 hours on days 2, 7, and 14 following start of treatment; A score is a number representing the total score or sum from 21 items or symptoms or manifestations of opiate withdrawal in newborn infants. The total score ranges from 0 to 43. Reference: 1. Finnegan LP, Connaughton JF, Jr., Kron RE, et al. Neonatal abstinence syndrome: assessment and management. Addict Dis 1975;2(1-2):141-58. Although normal newborn may manifest mild symptoms that will give scores in the range of 0 to 7. A score of 8 consecutively obtained times 3 indicate that infant will benefit from treatment, in this study morphine or clonidine. A decrease in scores especially to less than 8 is suggestive of a good response to treatment. (NCT01734551)
Timeframe: 14 days

Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)

The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50), attention (1.29 -8.4), Handling (0 - 1), quality of movement (1.20 - 6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43 - 6.67), hypertonicity (0- 8), hypotonicity (0 - 5.0), excitability (0-11), lethargy (0 - 11.0). and stress/abstinence (0. - 0.57). A higher score for each item means a higher level of the construct. For example, a higher score for hypertonicity means the infant is more hypertonic and higher score on hypotonicity means the infant is more hypotonic. No cut-off score published for normal or abnormal behavioral performance. Reference: Lester BM et al. Summary Statistics of Neonatal Intensive Care Unit Network Neurobehavioral Scale Scores From the Maternal Lifestyle Study: A Quasinormative Sample, in Pediatrics 2004; 113,668. (NCT01734551)
Timeframe: 5-10 days after treatment starts

Length of Treatment With Opioid Medication

Up to 12 months (NCT01723722)
Timeframe: Up to 12 months

Growth Outcome: Head Circumference at 18 Months

Average head circumference growth outcome at 18 month follow-up visit. (NCT01958476)
Timeframe: 18 month follow-up visit

Growth Outcome: Length at 18 Months

Average length (cm) at 18 month follow-up visit. (NCT01958476)
Timeframe: 18 month follow-up visit

Growth Outcome: Weight Change From Birth to 18 Months

Growth outcome weight (lbs) depicted as difference in averaged weights from birth to 18 month follow-up visit. Standard deviations were averaged between birth and 18 mo time points. (NCT01958476)
Timeframe: Birth to 18 month follow-up visit

Length of Hospital Stay (LOS)

Participants were monitored for the duration of their hospitalization, an expected mean of 22 days. (NCT01958476)
Timeframe: Participants will be monitored during their entire hospitalization, expected mean 22 days.

Length of Hospital Stay (LOS) Due to Neonatal Abstinence Syndrome (NAS)

Participants were monitored for the duration of their hospitalization attributable to NAS only. (NCT01958476)
Timeframe: Participants were monitored for the duration of their hospitalization, expected mean 22 days.

Length of Treatment (LOT)

Total number of days infant treated with replacement opioids while admitted to the hospital. (NCT01958476)
Timeframe: Participants were monitored for the duration of their hospitalization.

Number of Infants Needing a Dose Increase

"One Finnegan score ≥12, or two consecutive scores ≥8 affirms the requirement for pharmacological treatment or increasing treatment dosage. If the infant continued to have two consecutive Finnegan Scores ≥8 two times consecutively, or one ≥12, the dose was increased to the next level. (Level I: 0.3 mg/kg/day) (Level II: 0.5 mg/kg/day) (Level III: 0.7 mg/kg/day)~A higher Finnegan score indicates greater severity of NAS (min 0, max 50)." (NCT01958476)
Timeframe: Participants were monitored for the duration of their hospitalization, an average of 22 days.

Number of Infants Needing a Second NAS Medication

Number of infants treated with a second medication following protocol, phenobarbital. If the Finnegan Score remained elevated (still scored ≥8 two times consecutively, or still scored once ≥12) despite increasing to a predetermined maximal opioid dose (methadone or morphine), phenobarbital was administered (20-mg/kg loading dose followed by 4-5 mg/kg daily). (NCT01958476)
Timeframe: Participants were monitored for the duration of their hospitalization, an average of 22 days.

Cognitive, Language, and Motor Development From 18 Month Bayley III Neurodevelopmental Assessment

The Bayley Scales of Infant and Toddler Development (BSID-III) assesses the development of infants and children (1-42 months) through a series of developmental play tasks, identifying children with developmental delay. Raw scores of completed items are summarized within three distinct scale scores (Cognitive Scale, Language Scale, Motor Scale). Scale scores are each converted to composite scores to determine the child's performance compared with scores of age-matched children of typical development (percentile rank). A higher composite score indicates more ideal developmental outcome (range 40-160). At 18 month follow-up visit, participants were assessed using the BSID-III for cognitive, language and motor scale composite score outcomes. (NCT01958476)
Timeframe: Assessment at 18 month follow-up visit

Length of Hospitalization

This endpoint will compare length of stay in the hospital (in days) using sublingual buprenorphine or morphine solution. (NCT01452789)
Timeframe: Duration of hospital stay is an expected average of 5 weeks.

Length of Treatment

This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution. (NCT01452789)
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Adverse events will be collected, graded by severity, and assessed for causality referent to study drug. (NCT01452789)
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.

Number of Patients Requiring Supplemental Phenobarbital Treatment.

This endpoint will compare requirement number of patients who require use of supplemental phenobarbital. (NCT01452789)
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.

Reviews

8 reviews available for diazepam and Neonatal Abstinence Syndrome

Other Studies

5 other studies available for diazepam and Neonatal Abstinence Syndrome