Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004805
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
University of California, Los Angeles
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:

OBJECTIVES: I. Describe the psychosocial response of parents and caretakers who learn cardiopulmonary resuscitation (CPR) techniques for infants at high risk for respiratory or cardiac arrest.

II. Compare the effect of 4 methods of CPR instruction on psychosocial response.

III. Evaluate a psychological intervention based on social support theory designed to offset the potential adverse psychological outcomes of CPR instruction.

IV. Evaluate a self-paced CPR learning module using the principles of adult learning theory.

V. Document the level of CPR knowledge and skill retention over time. VI. Document the frequency of CPR and its outcome following a witnessed respiratory or cardiac arrest.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Bronchopulmonary Dysplasia Respiratory Distress Syndrome Behavioral: CPR instruction Not Applicable

Detailed Description:

PROTOCOL OUTLINE: Parents of high-risk infants are randomly assigned to 1 of 4 groups; groups are alternated at each site and the sequence of groups at each site is randomly assigned.

The first group receives a 90-minute, 1-person cardiopulmonary resuscitation (CPR) and obstructed airways management instruction.

The second group receives the same instruction plus a 1-hour social support discussion. Ongoing support is provided with weekly phone calls to assess caretaker status and answer questions regarding the infant's health.

The third group learns CPR using a self-paced multimedia learning module. The control group receives the standard CPR instruction at hospital discharge. Participants are followed at 2 weeks, then at 3 and 6 months.

Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Primary Purpose: Educational/Counseling/Training
Study Start Date : September 1991
Study Completion Date : August 1997

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Population Characteristics-- Parent or caretaker with infant at risk for sudden death, i.e.: Birth weight less than 2500 g Abnormal pneumogram Bronchopulmonary dysplasia Respiratory distress syndrome Primary pulmonary hypertension Congenital cardiac abnormality Home oxygen requirement Asphyxia or hypoxia Apnea of infancy Documented episode of apnea or bradycardia Sibling of sudden infant death syndrome victim Substance-abusing mother Literate in Spanish or English No history of mental illness No contraindication to cardiopulmonary resuscitation instruction, e.g., arthritis or orthopedic injury No cardiopulmonary resuscitation instruction within 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004805

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of California, Los Angeles
Study Chair: Kathleen Dracup University of California, Los Angeles Identifier: NCT00004805     History of Changes
Other Study ID Numbers: 199/11973
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2001

Keywords provided by Office of Rare Diseases (ORD):
bronchopulmonary dysplasia
cardiovascular and respiratory diseases
disease-related problem/condition
educational needs
hypertensive disorder
neonatal disorders
primary pulmonary hypertension
rare disease
respiratory distress syndrome

Additional relevant MeSH terms:
Hypertension, Pulmonary
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchopulmonary Dysplasia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury