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Clinical Trial Summary

This randomized control trial will compare buprenorphine and morphine, two currently used medications for the treatment of neonatal opioid withdrawal syndrome (NOWS), in newborns to determine which medication will reduce the number of days of pharmacological treatment.


Clinical Trial Description

This randomized control trial will compare buprenorphine to morphine, two currently used medications for the treatment of NOWS, to determine whether the use of buprenorphine for NOWS treatment will reduce the number of days of pharmacological treatment. After an infant is born they will be monitored for signs of NOWS. Once an infant reaches treatment thresholds, they will be randomized using a double dummy design to either the buprenorphine or morphine treatment arm. After randomization infants will receive a syringe with either morphine or placebo every 4 hours and every 8 hours infant will receive 1 sublingual application of buprenorphine or placebo. To maintain the blind infants enrolled in the study will receive both interventions. During the study medication doses will be weaned by 10% of the stabilization dose. Study intervention will continue until 20 percent of the maximal dose has been reached. Use of a second line drug will be permissible after randomization and after an infant has had 2 consecutive escalations. Second line drug will be phenobarbital, in addition to the study drug. Infants in both groups will be evaluated and scored for NOWS symptoms to determine if weaning study medication is permissible each day. NOWS scores that do not reach the threshold for escalation will wean in accordance with standard clinical practice. If NOWS symptoms increase during treatment, infants will have the dose of the study drug increased by 10% to the previous day's dose. When stable for 24 hours, the weaning process will continue. The NICU Network Neurobehavioral Scale (NNNS) will be administered prior to starting study medication and once off study medication but prior to discharge to examine proportion of infants in each medication arm for the abnormal NNNS profiles which has been associated with atypical early childhood outcomes including behavior problems and low IQ scores. Development at 18 months of age will also be assessed to examine any differences in both arms of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04455802
Study type Interventional
Source Women and Infants Hospital of Rhode Island
Contact
Status Withdrawn
Phase Phase 3
Start date October 1, 2020
Completion date May 17, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04214834 - Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) Phase 3
Recruiting NCT04834297 - Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome. N/A
Completed NCT04298853 - Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome Phase 4
Recruiting NCT05129020 - Neurostimulation to Improve NOWS Outcomes N/A
Active, not recruiting NCT03918850 - Medication Treatment for Opioid Use Disorder in Expectant Mothers Phase 3
Active, not recruiting NCT03911466 - Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study Phase 3
Recruiting NCT05937594 - MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
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Completed NCT04049799 - Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
Recruiting NCT04149509 - ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study