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Tips for Infant and Parent Sleep (TIPS)

T

The Hospital for Sick Children

Status

Completed

Conditions

Sleep Deprivation

Treatments

Behavioral: TIPS Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT00228215
1000007776

Details and patient eligibility

About

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 6 weeks later.

Full 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, development of the infant's sleep physiology, maternal sleep habits and behaviors, and maternal feelings related to her sleep and her baby's sleep. These factors may be modifiable through the use of behavioral-educational interventions. 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 6 weeks later. Sleep-wake patterns will be analyzed through the use of actigraphy, a wristwatch-like device that measures sleep-wake activity. This is a pilot study which will test the usefulness and practicality of this type of program, so that a larger scale study can be developed.

Enrollment

30 patients

Sex

All

Ages

8 hours to 7 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Usual care
No Intervention group
TIPS Intervention
Experimental group
Treatment:
Behavioral: TIPS Intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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