Prevention of Sudden DeathNCT00570869
Training Mothers of Infants in Infant Cardiopulmonary Resuscitation (CPR)
A study testing CPR Anytime in people with Prevention of Sudden Death, run by Lehigh Valley Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prevention of Sudden Death
- What is being tested?
- CPR Anytime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mother must be admitted to MBU at the CC site within twenty-four hours of giving birth.
- Mother must be eighteen years-old or greater.
Who cannot join
- Mother is not admitted to the MBU.
- Mother is under eighteen years-old.
- Mother has been inpatient for over twenty-four hours.
- Mother is physically incapable of performing CPR.
- Mother is cognitively impaired.
- Mother is unable to understand and sign consent.
Show all 10Show fewer
- Mother is non-English speaking.
- Current pregnancy resulted in fetal demise.
- Mother who has previously participated in the study.
- Mother who has previously self-educated themselves in infant CPR using a 22-minute DVD and an infant manikin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
About this study
Official title: 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.
Read more
Objectives
- 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.
- To determine if learning infant CPR with a 22-minute instructional DVD and infant manikin is as effective as attending traditional infant CPR class.
- 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.
- To examine the number of mothers who have been previously trained in CPR.
- To examine the reasons that mothers have been previously trained in CPR (e.g., mandated by work/career vs. personal reasons).
- 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.
Read the 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.
- Conditions
- Prevention of Sudden Death
- Being tested
- CPR Anytime
- Keywords
- Infant CPR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR AnytimeOther
These participants will be consented, surveyed, asked to watch a 22-minute instructional Infant CPR DVD with an infant manikin.
| Study group | Role | What they receive |
|---|---|---|
| CPR Class | Active comparator | 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). Receives: Other: CPR Anytime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants will be given written and practical exams to assess their learned CPR skills
Measured: 6 months
Secondary outcomes (1)
CPR learning experiences (e.g., ease, quality of instruction, convenience, ) will be analyzed from survey results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Sudden DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marna Rayl Greenberg, Lehigh Valley Hospital
- Investigators
- Marna R Greenberg, D.O., MPH, Principal investigator, LVH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570869
- Sponsor's protocol ID
- 2-20070911
- Status last verified
- Apr 2012
- First submitted
- 10 Dec 2007
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Mothers of Infants in Infant Cardiopulmonary Resuscitation (CPR) Using a 22-Minute Instructional DVD and Infant Manikin
- ClinicalTrials.gov ID
- NCT00570869
- Acronym / sponsor ID
- 2-20070911
- Conditions
- Prevention of Sudden Death
- Keywords
- Infant CPR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- To determine if learning infant CPR with a 22-minute instructional DVD and infant manikin is as effective as attending traditional infant CPR class.
- 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.
- To examine the number of mothers who have been previously trained in CPR.
- To examine the reasons that mothers have been previously trained in CPR (e.g., mandated by work/career vs. personal reasons).
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPR Class | Active comparator | Other: CPR Anytimemothers 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mother must be admitted to MBU at the CC site within twenty-four hours of giving birth.
- Mother must be eighteen years-old or greater.
Key exclusion criteria (10 listed)
- Mother is not admitted to the MBU.
- Mother is under eighteen years-old.
- Mother has been inpatient for over twenty-four hours.
- Mother is physically incapable of performing CPR.
- Mother is cognitively impaired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPR AnytimeThese participants will be consented, surveyed, asked to watch a 22-minute instructional Infant CPR DVD with an infant manikin. | Other | CPR Class |
Primary outcome
Participants will be given written and practical exams to assess their learned CPR skills
Time frame: 6 months
1 secondary outcome
CPR learning experiences (e.g., ease, quality of instruction, convenience, ) will be analyzed from survey results
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marna R Greenberg, D.O., MPH principal investigator
LVH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPR Anytime in people with Prevention of Sudden Death, run by Lehigh Valley Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants will be given written and practical exams to assess their learned CPR skills (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2012.