Clinical trial NCT00004805: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of California, Los Angeles
First posted: 2000-02-25
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: ECT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Kathleen Dracup
role: STUDY_CHAIR
References: