Changes in Sleep Patterns and Stress in Infants Entering Child Care

Changes in Sleep Patterns and Stress in Infants Entering Child Care: Implications for SIDS Risk

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.

Study Overview

• Status: Completed
• Conditions: Sudden Infant Death Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

infants from 0 to 3 months in the United States

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency	sleep efficieny is defined as the ratio of time spent asleep (total sleep time) to the amount of time spent in bed.	Days -14 through +14

Secondary Outcome Measures

Outcome Measure	Time Frame
Sleep duration	Days -14 to +14

Collaborators and Investigators

• Sponsor: Rachel Moon, MD
• Investigators: Principal Investigator: Rachel Y Moon, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: infant; stress levels; SIDS; sleep patterns; sudden infant death syndrome; licensed day care
• Additional Relevant MeSH Terms: Pathologic Processes; Death, Sudden; Death; Infant Death; Sudden Infant Death
• Other Study ID Numbers: 4453