Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228215
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2005-09-26
Brief Title:
Tips for Infant and Parent Sleep TIPS
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Tips for Infant and Parent Sleep TIPS Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 6 weeks later
Detailed Description:
Infant and maternal sleep in the postpartum are related and influenced by the mothers understanding of infant sleep behavior the environmental and social cues for sleep presented to the infant development of the infants sleep physiology maternal sleep habits and behaviors and maternal feelings related to her sleep and her babys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None