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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01265277
Enrollment
20
Registered
2010-12-23
Start date
2009-07-31
Completion date
2018-06-30
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Infant Death Syndrome

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Rachel Moon, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
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

Design outcomes

Primary

MeasureTime frameDescription
Sleep efficiencyDays -14 through +14sleep efficieny is defined as the ratio of time spent asleep (total sleep time) to the amount of time spent in bed.

Secondary

MeasureTime frame
Sleep durationDays -14 to +14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026