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

June 23, 2005 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment

900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Healthy term infants or infants at high epidemiologic risk for SIDS meeting one of the following criteria: Apnea of infancy Siblings of SIDS victim Preterm infants --Prior/Concurrent Therapy-- All study groups: No home treatment with supplemental oxygen, bronchodilators, diuretics, steroids, or respiratory stimulants other than methylxanthines Healthy term infants: No prior/concurrent medications or treatments except: Vitamins Eye prophylaxis Vaccines --Patient Characteristics-- All study groups: No concurrent pneumonia No history of congenital heart disease Current asymptomatic PDA or ASD, or small muscular VSD, not requiring treatment are allowed No ventriculoperitoneal shunt No home anticonvulsant therapy No congenital brain anomalies documented by head ultrasound, CT, or MRI No gastroesophageal reflux being treated by medication No midfacial hypoplasia or cleft palate No prior inborn error of metabolism (including MCAD or carnitine deficiency) No caregiver currently using illicit drugs No language barrier between researcher and caregiver Must have telephone in the home Healthy term infants: Gestational age at birth of 38-42 weeks Age no greater than 30 days postnatally for planned monitor start date Not admitted to a special care nursery Nursery discharge on/before date of maternal discharge or 48 hours of age, whichever is later No history of apnea or apparent life threatening event (ALTE) No history of SIDS in full or half siblings No history of SIDS in cousins, aunts, and uncles in the last 10 years 1 minute APGAR at least 4 5 minute APGAR at least 7 Apnea of infancy: Diagnosed ALTE (during sleep or awake) characterized by color change, muscle tone change, and apnea requiring intervention No specific etiology for the ALTE after a thorough diagnostic evaluation At least 12 hours of age and less than 6 months postnatal age when ALTE occurred Greater than 34 weeks gestation Weight greater than 1750 g Siblings of SIDS victim Half or full sibling of at least one previous SIDS victim Less than 1 month postnatal age at study entry Autopsy report confirmed SIDS in sibling Preterm infants Birth weight less than 1750 g Gestational age no greater than 34 weeks Postnatal age less than 120 days at time of hospital discharge

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

Yale University

Investigators

  • Study Chair: George Lister, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1994

Study Completion

August 1, 1999

Study Registration Dates

First Submitted

October 18, 1999

First Submitted That Met QC Criteria

October 18, 1999

First Posted (Estimate)

October 19, 1999

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/12190
  • YALESM-CHIME-HD9102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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