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Changes in Sleep Patterns and Stress in Infants Entering Child Care

NCT ID: NCT01265277

Last Updated: 2018-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sudden Infant Death Syndrome

Keywords

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sudden infant death syndrome SIDS infant licensed day care sleep patterns stress levels

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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at home

Infants 0-3 months who will stay at home with a parent

No interventions assigned to this group

child care

Infant 0-3 months who will attend a licensed child care center

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rachel Moon, MD

OTHER

Sponsor Role lead

Responsible Party

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Rachel Moon, MD

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rachel Y Moon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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4453

Identifier Type: -

Identifier Source: org_study_id