Maternal Acupuncture and Neonatal Abstinence Syndrome
| ISRCTN | ISRCTN52062666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52062666 |
| Secondary identifying numbers | CAM 05-325 |
- Submission date
- 09/09/2005
- Registration date
- 20/01/2006
- Last edited
- 24/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Patricia Janssen
Scientific
Scientific
University of British Columbia (UBC) Dept of Health Care and Epidemiology
5804 Fairvew Ave
Vancouver
V6T-1Z3
Canada
| Phone | +1 604 875 2424, local 5414 |
|---|---|
| pjanssen@interchange.ubc.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Infants whose mothers have been randomized to receive standard care (methadone maintenance) in combination with daily acupuncture treatments versus standard care alone will require fewer days of treatment with morphine for neonatal abstinence syndrome. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Drug addiction |
| Intervention | Acupuncture using National Acupuncture Detoxification Association (NADA) protocol + standard care versus standard care alone. |
| Intervention type | Other |
| Primary outcome measure | Days of neonatal morphine treatment |
| Secondary outcome measures | 1. Gestational age at birth 2. Rates of intrauterine growth restriction 3. Scores on the Neonatal Abstinence Syndrome Scale 4. Rates of admission to a level II or level III nursery and length of stay 5. Days to regain birthweight 6. Rates of apprehension by the Ministry of Children and Families prior to discharge from hospital |
| Overall study start date | 01/08/2005 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 180 |
| Key inclusion criteria | All women admitted to the Chemical Dependency Unit at BC Womens Hospital will be offered participation. |
| Key exclusion criteria | Women who can neither read nor write English. |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of British Columbia (UBC) Dept of Health Care and Epidemiology
Vancouver
V6T-1Z3
Canada
V6T-1Z3
Canada
Sponsor information
Toronto SickKids Foundation (Canada)
Charity
Charity
555 University Avenue
Toronto
M5G-1X6
Canada
| Website | http://www.sickkids.ca |
|---|---|
"ROR" |
https://ror.org/04374qe70 |
Funders
Funder type
Charity
Toronto Sickkids Foundation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/12/2012 | Yes | No |
