Status:
COMPLETED
Tips for Infant and Parent Sleep (TIPS)
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Sleep Deprivation
Eligibility:
All Genders
8-7 years
Phase:
NA
Brief Summary
A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep ...
Detailed Description
Infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the infant, dev...
Eligibility Criteria
Inclusion
- Singleton baby born at GA \>37 weeks
- baby 8 hours to 7 days old
- Mother age 16-50 years
- Normal, healthy infant as described in newborn examination
- First time parents living in the Greater Toronto Area
- Mother planning to provide fulltime care to her infant for at least the first six weeks after discharge home
Exclusion
- Maternal or infant complications requiring prolonged hospital stay
- Previous stillbirth or neonatal death
- Maternal chronic illness
- Maternal use of medications that affect sleep (e.g. benzodiazepines, any sleep aid)
- Known drug or alcohol use beyond occasional social use
- Smoking two packs a day or more
- Either parent has a diagnosed sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
- Mother's partner is working night shifts
- Mother unable to read or understand English
- No telephone in the home
- Involvement in another research protocol involving sleep
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00228215
Start Date
September 1 2005
End Date
December 1 2005
Last Update
September 13 2019
Active Locations (2)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
2
Sunnybrook & Women's Health Sciences Centre - Women's College Campus
Toronto, Ontario, Canada, M5S 1B2