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| Sponsored by: |
University of British Columbia |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00225316 |
Purpose
To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women..
| Condition | Intervention | Phase |
|---|---|---|
|
Substance Addiction |
Procedure: Acupuncture |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Can Maternal Acupuncture for Chemically Dependent Pregnant Women Reduce the Severity of Neonatal Abstinence Syndrome? - A Randomized Controlled Trial |
| Estimated Enrollment: | 180 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Potential study subjects will be recruited from the Chemical Dependency Unit by a trial coordinator. After obtaining written informed consent, the coordinator will take a sequentially numbered opaque envelope from a box on the unit. This envelope will contain a card indicating the treatment group to which the woman is allocated. Women participating in the treatment group of our study will have access to a quiet room furnished with comfortable reclining chairs. The acupuncturist will swab the ears with alcohol and insert sterile, disposable needles. Following the treatment, which is 45-minutes in length, participants will remove the needles themselves and place them in protective sharps boxes. A sham acupuncture procedure will not be used. Chinese traditional medicine does not include the concept of a placebo. Those who argue that auricular acupuncture stimulates the vagus nerve, which innervates the ear concha state that needles placed anywhere in the concha should produce the same effects. 58 Studies utilizing sham procedures have failed to show a difference between the control and active experimental conditions.
In this unit, morphine is prescribed for the neonate by pediatricians (11 in total) if there is a constellation of symptoms unresponsive to environmental control including: 1) convulsions, 2) inconsolability or crying continuously for 3 hours, 3) persistent tremors or jitteriness when undisturbed, 4) continuous central nervous system irritability including hyperactive Moro reflex, tremors, jitteriness, increased muscle tone and unprovoked muscle jerks, 5) persistent vomiting or projectile vomiting over a 12 hour period; or 6) explosive diarrhea for 2-3 consecutive episodes.
Additional clinical signs such as tachycardia, tachypnea, watery stools, fever, or weight loss > 10% may justify use of morphine after consideration of differential diagnoses. Morphine 1mg/ml is started at a rate of 0.03 mg/kg/dose every 3 hours. The dose is reviewed daily and titrated based on daily weights and ongoing symptoms.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Women admitted to the chemical dependency unit at BC Women's Hospital, Vancouver, B.C.
Exclusion Criteria:
Contacts and Locations| Contact: Cheri Naslund | 604-875-2424 ext 5372 |
| Canada, British Columbia | |
| BC Women's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3N1 | |
| Contact: Cheri Naslund 604-875-2424 ext 5372 | |
| Principal Investigator: Patricia Janssen, PhD | |
| Principal Investigator: | Dr. Patricia Janssen | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr. Patricia Janssen ) |
| Study ID Numbers: | W05-0041, 04-2985 |
| Study First Received: | September 21, 2005 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00225316 History of Changes |
| Health Authority: | Canada: Health Canada |
|
RCT intervention study addiction substance use pregnancy |
|
Behavior, Addictive Mental Disorders Neonatal Abstinence Syndrome |
Substance-Related Disorders Disorders of Environmental Origin Infant, Newborn, Diseases |
|
Mental Disorders Neonatal Abstinence Syndrome Substance-Related Disorders Disorders of Environmental Origin Infant, Newborn, Diseases |