Changes in Sleep Patterns and Stress in Infants Entering Child Care

Sponsor

Rachel Moon, MD (Other)

Overall Status

Completed

CT.gov ID

NCT01265277

Collaborator

(none)

Enrollment

Location

107

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Sleep efficiency [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 [Days -14 to +14]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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