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Trial record 4 of 17 for:    "Sudden infant death syndrome"

Changes in Sleep Patterns and Stress in Infants Entering Child Care

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Rachel Moon, MD, University of Virginia Identifier:
First received: December 20, 2010
Last updated: June 30, 2017
Last verified: June 2017
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.

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

Resource links provided by NLM:

Further study details as provided by Rachel Moon, MD, University of Virginia:

Primary Outcome Measures:
  • Sleep efficiency [ Time Frame: Days -14 through +14 ]
    sleep efficieny is defined as the ratio of time spent asleep (total sleep time) to the amount of time spent in bed.

Secondary Outcome Measures:
  • Sleep duration [ Time Frame: Days -14 to +14 ]

Biospecimen Retention:   Samples Without DNA
urine samples from both mom and baby

Enrollment: 20
Actual Study Start Date: July 2009
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01265277

United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20010
Sponsors and Collaborators
Rachel Moon, MD
Principal Investigator: Rachel Y Moon, MD University of Virginia
  More Information

Responsible Party: Rachel Moon, MD, MD, University of Virginia Identifier: NCT01265277     History of Changes
Other Study ID Numbers: 4453
Study First Received: December 20, 2010
Last Updated: June 30, 2017

Keywords provided by Rachel Moon, MD, University of Virginia:
sudden infant death syndrome
licensed day care
sleep patterns
stress levels

Additional relevant MeSH terms:
Infant Death
Sudden Infant Death
Pathologic Processes
Death, Sudden processed this record on September 21, 2017