|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
University of California, Los Angeles |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004805 |
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: | Educational/Counseling/Training |
| Estimated Enrollment: | 500 |
| Study Start Date: | September 1991 |
| Estimated Study Completion Date: | August 1997 |
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 |
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 More Information
| Study ID Numbers: | 199/11973, UCLA-94061792 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004805 History of Changes |
| Health Authority: | United States: Federal Government |
|
bronchopulmonary dysplasia cardiovascular and respiratory diseases disease-related problem/condition educational needs hypertensive disorder |
neonatal disorders primary pulmonary hypertension rare disease respiratory distress syndrome |
|
Disease Respiration Disorders Respiratory Distress Syndrome, Adult Vascular Diseases Infant, Premature, Diseases Bronchopulmonary Dysplasia Pathologic Processes |
Respiratory Tract Diseases Hypertension, Pulmonary Syndrome Lung Diseases Infant, Newborn, Diseases Cardiovascular Diseases Hypertension |
