Changes in Sleep Patterns and Stress in Infants Entering Child Care

NCT01265277 | Completed

• 1 other identifier: 4453
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Infant Death Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sleep duration

  Days -14 to +14

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

infants from 0 to 3 months in the United States

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rachel Moon, MD: lead

Study Sites (1)

Children's National Medical Center

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples from both mom and baby

MeSH Terms

Conditions

Sudden Infant Death

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachel Y Moon, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 23, 2010
• Study Start: July 1, 2009
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 10, 2018

Record last verified: 2018-12

Locations

US (1)