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The TIPS (Tips for Infant and Parent Sleep) trial
ISRCTN ISRCTN13501166
DOI 10.1186/ISRCTN13501166
ClinicalTrials.gov identifier
EudraCT number
Public title The TIPS (Tips for Infant and Parent Sleep) trial
Scientific title Tips for Infant and Parent Sleep: a randomised, blinded, parallel assignment trial
Acronym TIPS
Serial number at source MCT-84658
Study hypothesis Primary question:
Compared to usual care, what is the effect of a behavioural-educational sleep intervention in the early postpartum on maternal nocturnal sleep?

Secondary question:
Compared to usual care, what is the effect of a behavioural-educational sleep intervention in the early postpartum on length of an infant's longest nocturnal sleep period?

Additional research questions will address the effects of a behavioural-educational sleep intervention in the early postpartum on: maternal nighttime awakenings, infant nighttime awakenings, maternal sleep disturbance, depressive symptomatology, maternal morning fatigue, and breastfeeding.

Please note that as of 04/03/2009 the anticipated end date in this record was amended; the previous date was as follows:
Initial anticipated end date: 01/12/2008
Lay summary Not provided at time of registration
Ethics approval Ethics committees of:
1. Sunnybrook Health Sciences Centre, Toronto approved on the 27th November 2007
2. St Michael's Hospital, Toronto approved on the 4th February 2008
3. University of Toronto approved on the 9th March 2007
Study design Randomised, blinded (investigator, data analyst, research nurse), parallel assignment trial
Countries of recruitment Canada
Disease/condition/study domain Sleep disorders
Participants - inclusion criteria 1. Women (single or partnered), no age limit
2. Have given birth for the first time
3. Have a singleton baby born at gestational age (GA) greater than or equal to 37 weeks
4. Have a baby described as healthy in the newborn examination
5. Live in the greater Toronto area
6. Plan to provide full time infant care for at least the first 12 weeks after birth
7. Women with previous miscarriages at less than 20 weeks GA are eligible if the most recent pregnancy resulted in a first child
Participants - exclusion criteria 1. Women or women whose partners have experienced stillbirth or perinatal death at greater than or equal to 20 weeks GA
2. Women whose partners have children from another relationship
3. Maternal or infant complications requiring prolonged hospital stay
4. Maternal chronic illness that is poorly controlled
5. Maternal use of medications that affect sleep (e.g. benzodiazepines)
6. Maternal (or partner, if they exist) drug or alcohol use beyond social use
7. Women (or partners, if one exists) with a diagnosed sleep disorder (e.g. sleep apnoea, narcolepsy)
8. Mother's partner, if one exists, is working night shifts
9. Mother unable to read or understand English
10. No telephone in the home
11. Involvement in another research study involving sleep
Anticipated start date 30/05/2008
Anticipated end date 15/04/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 234
Interventions Experimental:
TIPS (45-minute behavioural-educational session with a Research Nurse [RN] in hospital, 20-page booklet, 3 phone calls at home in the postpartum).

Control:
Usual care (three phone calls at home to provide attention only).
Primary outcome measure(s) Maternal nocturnal (9 pm - 9 am) sleep (in minutes) as measured at 6 and 12 weeks postpartum.
Secondary outcome measure(s) Infant's longest nocturnal (9 pm - 9 am) sleep period (in minutes) as measured at 6 and 12 weeks postpartum.
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-84658)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23516146
Contact name Dr  Robyn  Stremler
  Address Faculty of Nursing
University of Toronto
Room 288, 155 College Street
  City/town Toronto
  Zip/Postcode M5T 1P8
  Country Canada
  Tel +1 416 978 6925
  Fax +1 416 978 8222
  Email robyn.stremler@utoronto.ca
Sponsor University of Toronto (Canada)
  Address 27 King's College Circle
  City/town Toronto
  Zip/Postcode M5S 1A1
  Country Canada
  Sponsor website: http://www.utoronto.ca/
Date applied 03/07/2008
Last edited 28/05/2013
Date ISRCTN assigned 03/07/2008
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