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The TIPS (Tips for Infant and Parent Sleep) trial

Tips for Infant and Parent Sleep: a randomised, blinded, parallel assignment trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13501166
Enrollment
234
Registered
2008-07-03
Start date
2008-05-30
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disorders Nervous System Diseases Nonorganic sleep disorders

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 call

Sponsors

University of Toronto (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Maternal nocturnal (9 pm - 9 am) sleep (in minutes) as measured at 6 and 12 weeks postpartum.

Secondary

MeasureTime frame
Infant's longest nocturnal (9 pm - 9 am) sleep period (in minutes) as measured at 6 and 12 weeks postpartum.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026