Sudden Infant Death SyndromeSIDSNCT01361893
Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)
A study testing Lifestyle Counseling in people with Sudden Infant Death Syndrome, run by University of Virginia at 1 site in United States.
Trial summary
The overall purpose of this investigation is to better understand factors contributing to the high incidence of prone sleep positioning in African-American infants. In addition, the investigators are interested in investigating other races and ethinicities to understand their beliefs and perceptions and determine… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death Syndrome
- What is being tested?
- Lifestyle Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Sep 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents who are 18 years old wth children less than 6 months old are eligible to participate if they self-identify as African American, with parents born in the United States.
Who cannot join
- If the parent is male, not the custodial parent of the child, unable to complet the interview in English or if their child has a chronis illness that would preclude use of the supine sleep position, severe gastroesophageal reflux or recent spinal surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
The overall purpose of this investigation is to better understand factors contributing to the high incidence of prone sleep positioning in African-American infants. In addition, the investigators are interested in investigating other races and ethinicities to understand their beliefs and perceptions and determine differences socioeconomically and socioculturally within and between groups. The investigators will address the following specific aims:
(-) To compare knowledge, attitudes, and practices regarding infant sleep position in parents of higher and lower SES.
(-) To identify risk factors for non-use of recommended supine sleep position in families with higher and lower SES (-) to develop a phenomenologic understanding of the decisions made by parents of higher SES and lower SES who do nt use recommended supine sleep position, using qualitative techniques.
Read the detailed description
Epidemiologic studies have demonstrated prone position to be a major risk factor for SIDS. Studies have consistently demonstrated an increased rate of prone positioning in African American infants, but very little is known about the reasons why African American parents use the prone position more often than other racial groups. Furthermore, no studies have taken advantage of the observed socioeconomic status associated variablility in SIDS and prone sleeping within the African American community. By examing within-group differences, it is possible to move beyond comparative racial descriptions (i.e. comparisions of white and African American) to identification of potentially modifiable factors that might respond to culturally acceptable interventions within a disadvantaged group.
- Conditions
- Sudden Infant Death Syndrome
- Being tested
- Lifestyle Counseling
- Keywords
- SIDS, African American, Infants, Disparity
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingOther
Also called African American, Qualitative, Quantitative, SIDS
We will utilize a combination of quantitative and qualitative techniques to ascertain factors, attitudes, and beliefs of African American parents of infants less than 6 months old.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Counseling | Other | Parents who qualify for the study will be asked to participate in the survey portion of the study. informed consent will be obtained. After completing the survey each parent will be asked if they would be willing to participate in and additional interview (focus group or semi-structured in-debth interview) at a later date. Receives: Other: Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors Influencing the Racial Disparity in SIDS
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)
Measured: December 2004 - June 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startDec 2004
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Infant Death SyndromeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), March of Dimes
- Responsible party
- Principal investigator, Rachel Moon, MD, Children's National Research Institute
- Investigators
- Rachel Y Moon, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361893
- Sponsor's protocol ID
- 3488
- Other IDs
- K24RR023681
- Acronym
- SIDS
- Status last verified
- Oct 2018
- First submitted
- 12 May 2011
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)
- ClinicalTrials.gov ID
- NCT01361893
- Acronym / sponsor ID
- SIDS / 3488
- Conditions
- Sudden Infant Death Syndrome
- Keywords
- SIDS, African American, Infants, Disparity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), March of Dimes
- Study start
- Dec 2004
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 May 2011 (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.
The overall purpose of this investigation is to better understand factors contributing to the high incidence of prone sleep positioning in African-American infants. In addition, the investigators are interested in investigating other races and ethinicities to understand their beliefs and perceptions and determine differences socioeconomically and socioculturally within and between groups. The investigators will address the following specific aims:
(-) To compare knowledge, attitudes, and practices regarding infant sleep position in parents of higher and lower SES.
(-) To identify risk factors for non-use of recommended supine sleep position in families with higher and lower SES (-) to develop a phenomenologic understanding of the decisions made by parents of higher SES and lower SES who do nt use recommended supine sleep position, using qualitative techniques.
Detailed description
Epidemiologic studies have demonstrated prone position to be a major risk factor for SIDS. Studies have consistently demonstrated an increased rate of prone positioning in African American infants, but very little is known about the reasons why African American parents use the prone position more often than other racial groups. Furthermore, no studies have taken advantage of the observed socioeconomic status associated variablility in SIDS and prone sleeping within the African American community. By examing within-group differences, it is possible to move beyond comparative racial descriptions (i.e. comparisions of white and African American) to identification of potentially modifiable factors that might respond to culturally acceptable interventions within a disadvantaged group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Counseling | Other | Other: Lifestyle CounselingParents who qualify for the study will be asked to participate in the survey portion of the study. informed consent will be obtained. After completing the survey each parent will be asked if they would be willing to participate in and additional interview (focus group or semi-structured in-debth interview) at a later date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents who are 18 years old wth children less than 6 months old are eligible to participate if they self-identify as African American, with parents born in the United States.
Key exclusion criteria (1 listed)
- If the parent is male, not the custodial parent of the child, unable to complet the interview in English or if their child has a chronis illness that would preclude use of the supine sleep position, severe gastroesophageal reflux or recent spinal surgery.
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 |
|---|---|---|
| Lifestyle CounselingAlso: African American, Qualitative, Quantitative, SIDSWe will utilize a combination of quantitative and qualitative techniques to ascertain factors, attitudes, and beliefs of African American parents of infants less than 6 months old. | Other | Lifestyle Counseling |
Primary outcome
Factors Influencing the Racial Disparity in SIDS
Time frame: December 2004 - June 2011
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)
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 19 Oct 2018.
Related trials for Sudden Infant Death Syndrome
Recruiting
Infant Safe Sleep in Pediatric Emergency Depratment
Infant Safe Sleep Practices, SIDS
Enrolling by invitationPhase 2/3
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Mucopolysaccharidosis II
Active, not recruitingPhase 2/3
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
Mucopolysaccharidosis Type II, Metabolic Diseases
Active, not recruitingPhase 2/3
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)
Mucopolysaccharidosis II
Active, not recruitingObservational study
Long-term Follow-Up for RGX-121
Mucopolysaccharidosis II
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.
Rachel Y Moon, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Counseling in people with Sudden Infant Death Syndrome, run by University of Virginia 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 1 inclusion and 1 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 19 Oct 2018. 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?
Factors Influencing the Racial Disparity in SIDS (time frame: December 2004 - June 2011). 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 19 Oct 2018.