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

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004805
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: February 2001
  Purpose

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 Intervention
Pulmonary Hypertension
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome
Behavioral: CPR instruction

Study Type: Interventional
Study Design: Primary Purpose: Educational/Counseling/Training

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 500
Study Start Date: September 1991
Estimated Study Completion Date: August 1997
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004805

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Study Chair: Kathleen Dracup University of California, Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004805     History of Changes
Other Study ID Numbers: 199/11973, UCLA-94061792
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 16, 2014