Maternal Acupuncture and Neonatal Abstinence Syndrome

ISRCTN	ISRCTN52062666
DOI	https://doi.org/10.1186/ISRCTN52062666
Protocol serial number	CAM 05-325
Sponsor	Toronto SickKids Foundation (Canada)
Funder	Toronto Sickkids Foundation

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Patricia Janssen
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
Email	pjanssen@interchange.ubc.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Days of neonatal morphine treatment
Key secondary outcome measure(s)	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
Completion date	01/08/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

University of British Columbia (UBC) Dept of Health Care and Epidemiology

Vancouver
V6T-1Z3
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/12/2012		Yes	No