Incidence and Severity of Cardiorespiratory Events in Infants at Increased Epidemiological Risk for Sudden Infant Death Syndrome (SIDS)

Completed

• Conditions: Sudden Infant Death Syndrome; Apnea

• Registration Number: NCT00004392
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

OBJECTIVES: I. Assess and compare the incidence and severity of cardiorespiratory events documented by home monitoring in infants at increased epidemiological risk for sudden infant death syndrome (SIDS).

II. Determine the antecedent medical, demographic, physiologic, and behavioral characteristics that predict the incidence of cardiorespiratory events documented by home monitoring.

Detailed Description

PROTOCOL OUTLINE: This is a multicenter collaborative study. Patients are stratified into 4 groups: healthy term infants, apnea of infancy, subsequent siblings of SIDS victims, and preterm infants.

The caregivers are trained in the use of home monitor equipment and in the graded response to monitor alarms (observation, gentle stimulation, more vigorous stimulation, mouth to mouth breathing, and full cardiopulmonary resuscitation).

Caregivers undergo infant cardiopulmonary resuscitation (CPR) training (not required for caregivers of healthy term infants).

Demographic information is obtained on each infant. A 30 second recording of each infant's cry is performed at study entry and at 1 month corrected age, and at the polysomnogram. A urine sample is collected and frozen.

The CHIME monitor is used during sleep and whenever the infant is not being observed.

An overnight polysomnography is performed within 2 weeks of study entry. At 1, 2.5, 6, and 12 months corrected age, infants participate in a clinical evaluation. Neurodevelopmental status is assessed at 1, 4, and 12 months corrected age.

Study Timeline

• Study Start: 1994-05
• Study Completion: 1999-08
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2000-01
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified