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

Primary Purpose

Pulmonary Hypertension, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPR instruction
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Pulmonary Hypertension focused on measuring bronchopulmonary dysplasia, cardiovascular and respiratory diseases, disease-related problem/condition, educational needs, hypertensive disorder, neonatal disorders, primary pulmonary hypertension, rare disease, respiratory distress syndrome

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004805
    Brief Title
    Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 1997 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of California, Los Angeles

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
    Keywords
    bronchopulmonary dysplasia, cardiovascular and respiratory diseases, disease-related problem/condition, educational needs, hypertensive disorder, neonatal disorders, primary pulmonary hypertension, rare disease, respiratory distress syndrome

    7. Study Design

    Primary Purpose
    Educational/Counseling/Training
    Study Phase
    Not Applicable
    Enrollment
    500 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    CPR instruction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen Dracup
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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