Changes in Sleep Patterns and Stress in Infants Entering Child Care
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Purpose
When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.
| Condition |
|---|
|
Sudden Infant Death Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Changes in Sleep Patterns and Stress in Infants Entering Child Care: Implications for SIDS Risk |
- Sleep efficiency [ Time Frame: Days -14 through +14 ] [ Designated as safety issue: No ]sleep efficieny is defined as the ratio of time spent asleep (total sleep time) to the amount of time spent in bed.
- Sleep duration [ Time Frame: Days -14 to +14 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
urine samples from both mom and baby
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
at home
Infants 0-3 months who will stay at home with a parent
|
|
child care
Infant 0-3 months who will attend a licensed child care center
|
Detailed Description:
The overall aim of this study is to describe sleep patterns in infants as they transition from home to child care, including 24-hour sleep duration, changes in the timing of daytime naps, and changes in nocturnal sleep periods; to describe potential sleep disrupters, such as temperature, light and noise, in home and child care settings that may impact sleep quality and sleep patterns; to describe markers of parent and infant stress levels during the transition to child care; to describe markers of infant circadian rhythm during the transition to child care.
Eligibility| Ages Eligible for Study: | up to 3 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
infants from 0 to 3 months in the United States
Inclusion Criteria:
- Infants who are less than 3 months of age from English-speaking families where one or both parents live in the household will be eligible to participate. If the infant will be entering child care, the infant must be entering a licensed child care center, and child care entry must be between 60 and 120 days of age.
Exclusion Criteria:
- S/he was born prematurely, with a gestational age less than 37 weeks at birth, or had a birth weight <2500 grams (5-1/2 lbs)
- S/he has any medical problems that require ongoing care by a subspecialty physician
Contacts and Locations| Contact: Brandi Joyner, MSA | (202) 476-4913 | bljoyner@cnmc.org |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Principal Investigator: | Rachel Y Moon, MD | Children's Research Institute |
More Information
No publications provided
| Responsible Party: | Children's Research Institute |
| ClinicalTrials.gov Identifier: | NCT01265277 History of Changes |
| Other Study ID Numbers: | 4453 |
| Study First Received: | December 20, 2010 |
| Last Updated: | April 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Research Institute:
|
sudden infant death syndrome SIDS infant |
licensed day care sleep patterns stress levels |
Additional relevant MeSH terms:
|
Death Sudden Infant Death Pathologic Processes Death, Sudden |
ClinicalTrials.gov processed this record on May 23, 2013