Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
NCT ID: NCT04298853
Last Updated: 2022-10-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
17 participants
INTERVENTIONAL
2020-06-30
2021-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
NCT02851303
Improving Outcomes in Neonatal Abstinence Syndrome
NCT01958476
NAS Treatment - Opiate Versus Non-Opiate
NCT01734551
Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
NCT01804075
The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
NCT01754324
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard
Infants randomized to the standard arm will receive morphine based on the current institutional treatment protocol: oral morphine 0.05 mg/kg/dose given every 3 hours, initiated if threshold Finnegan score is met. Once stabilized, dose will be weaned by 10% of peak dose per day until discontinuation.
Morphine scheduled
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
Study
Infants randomized to the study arm will receive oral morphine 0.05 mg/kg/dose as needed for an elevated Finnegan score. May receive morphine as frequently as every 3 hours if needed.
Morphine PRN
Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Morphine PRN
Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
Morphine scheduled
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* intrauterine opioid exposure
* signs and symptoms of opioid withdrawal
Exclusion Criteria
* co-morbid conditions that require sedation or analgesia due to clinical condition
* ongoing need for respiratory support
28 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anna Thomas
Assistant Professor of Clinical Pediatrics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1910620136
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.