Changes in Sleep Patterns and Stress in Infants Entering Child Care

Sudden Infant Death Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265277
• Other study ID #: 4453
• Status: Completed
• Start date: July 2009
• Est. completion date: June 2018

Study information

• Verified date: December 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Death
• Sudden Infant Death
• Sudden Infant Death Syndrome

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Rachel Moon, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sleep duration		Days -14 to +14