Completed

Four Methods of Cardiopulmonary Resuscitation Instruction and Psychosocial Response in Parents of High-Risk Infants

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What is being tested

CPR instruction

Behavioral
Who is being recruted

Cardiovascular Diseases+16

+ Infant, Premature, Diseases

+ Lung Diseases

See all eligibility criteria
How is the trial designed

Educational Study

Interventional
Study Start: September 1991
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1991

Actual date on which the first participant was enrolled.

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.

NCT00004805
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Educational/Counseling/Training (ECT)

These studies test ways to help people better understand their health or care. They may offer information, support, or skills training to improve how someone manages a condition or makes health decisions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesInfant, Premature, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesRespiration DisordersPathological Conditions, Signs and SymptomsVascular DiseasesDisease AttributesLung InjuryVentilator-Induced Lung InjuryBronchopulmonary DysplasiaHypertensionHypertension, PulmonaryInfant, Newborn, DiseasesRespiratory Distress SyndromeRespiratory Tract DiseasesRare DiseasesFamilial Primary Pulmonary Hypertension

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers