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Trial record 6 of 103 for:    SIDS

Changes in Sleep Patterns and Stress in Infants Entering Child Care

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265277
First Posted: December 23, 2010
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rachel Moon, MD, University of Virginia
  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

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)
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265277


Locations
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
Investigators
Principal Investigator: Rachel Y Moon, MD University of Virginia
  More Information

Responsible Party: Rachel Moon, MD, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01265277     History of Changes
Other Study ID Numbers: 4453
First Submitted: December 20, 2010
First Posted: December 23, 2010
Last Update Posted: July 2, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Infant Death
Sudden Infant Death
Death
Pathologic Processes
Death, Sudden