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OpenTrials
Completed

NCT Number: NCT01265277

Changes in Sleep Patterns and Stress in Infants Entering Child Care

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.

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Key information

Conditions

Sudden Infant Death Syndrome Death Death, Sudden Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Infant Death

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sleep efficiency

    Time frame: 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 outcomes

  1. Sleep duration

    Time frame: Days -14 to +14

Sponsors and collaborators

Lead sponsor

Rachel Moon, MD

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Dec 23, 2010
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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