Training Mothers of Infants in Infant Cardiopulmonary Resuscitation (CPR)

April 25, 2012 updated by: Marna Rayl Greenberg, Lehigh Valley Hospital

Training Mothers of Infants in Infant Cardiopulmonary Resuscitation (CPR) Using a 22-Minute Instructional DVD and Infant Manikin

This research will be a prospective, cohort study to determine if mothers of infants/newborns are more willing to complete CPR training using a 22-minute instructional DVD and infant manikin versus traditional four hour didactic instruction.

Study Hypothesis: A 22-minute instructional DVD and infant manikin will be an effective and preferred tool for teaching mothers of infants infant CPR.

Objectives

  1. To determine if mothers of infants are more likely to complete infant CPR training with a 22-minute instructional DVD and infant manikin, than by attending a traditional CPR class.
  2. To determine if learning infant CPR with a 22-minute instructional DVD and infant manikin is as effective as attending traditional infant CPR class.
  3. To examine the number of mothers that were offered the opportunity to learn infant CPR either as part of their prenatal classes, or upon the birth of their infant.
  4. To examine the number of mothers who have been previously trained in CPR.
  5. To examine the reasons that mothers have been previously trained in CPR (e.g., mandated by work/career vs. personal reasons).
  6. To examine the multiplier effect of an at home CPR education using a 22-minute instructional DVD and infant manikin at the time of the follow up phone call.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research will be a prospective, cohort study to determine if mothers of infants/newborns are more willing to complete CPR training using a 22-minute instructional DVD and infant manikin versus traditional four hour didactic instruction. Participants of the study will include mothers ages eighteen years and older, being treated as inpatients on the Mother Baby Unit (MBU) at the Cedar Crest (CC) site. Participants must have given birth within the last twenty-four hours, to a baby receiving care in the MBU nursery or the Neonatal Intensive Care Unit (NICU). Consent will be obtained from mother to participate. The control group will consist of those mothers who are currently certified in CPR (i.e., have taken the traditional CPR class, or have been recertified in CPR by classroom instruction, within the past two years). It is expected that this group will not have many participants because it is predicted that not many mothers will be certified in infant CPR prior to giving birth. After being consented, mothers will be surveyed, and tested on their CPR knowledge and proficiency before hospital discharge. The experimental group will consist of those participants who are not currently certified in CPR (i.e., have had traditional CPR training over two years ago which has lapsed, or who have never been certified in CPR). These participants will be consented, surveyed, asked to watch a 22-minute instructional DVD with an infant manikin, and then tested on CPR knowledge and proficiency before hospital discharge. Surveys will include questions pertaining to participant demographics, previous CPR learning experiences, reasons for obtaining and approximate cost of previous CPR instruction, and rating their instructional experiences (e.g., ease, quality of instruction, convenience, and effectiveness). Research staff will become CPR Instructors; and to ensure the inter-rater reliability each member of the staff will independently score CPR knowledge and performance in a series of mock CPR testing scenarios. During the study, research staff will be blinded to the group that the participants are enrolled in. Therefore, if one research staff member enrolls the participant, another blinded research staff member will assess the participants CPR proficiency in order to eliminate any instructor bias. Follow-up phone calls will be conducted 6 months post enrollment to measure the multiplier effect and to inquire about the incidence of having to use CPR skills in a real-life situation. Scores on participant's written and practical tests, responses to survey questions and follow up phone calls will be compared between groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Mother must be admitted to MBU at the CC site within twenty-four hours of giving birth.
  2. Mother must be eighteen years-old or greater.

Exclusion Criteria:

  1. Mother is not admitted to the MBU.
  2. Mother is under eighteen years-old.
  3. Mother has been inpatient for over twenty-four hours.
  4. Mother is physically incapable of performing CPR.
  5. Mother is cognitively impaired.
  6. Mother is unable to understand and sign consent.
  7. Mother is non-English speaking.
  8. Current pregnancy resulted in fetal demise.
  9. Mother who has previously participated in the study.
  10. Mother who has previously self-educated themselves in infant CPR using a 22-minute DVD and an infant manikin.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CPR Class
mothers who are currently certified in CPR (i.e., have taken the traditional CPR class, or have been recertified in CPR by classroom instruction, within the past two years).
Other: CPR Anytime
These participants will be consented, surveyed, asked to watch a 22-minute instructional Infant CPR DVD with an infant manikin.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Participants will be given written and practical exams to assess their learned CPR skills
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
CPR learning experiences (e.g., ease, quality of instruction, convenience, ) will be analyzed from survey results
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lehigh Valley Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marna R Greenberg, D.O., MPH, LVH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2-20070911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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