Sudden Infant Death SyndromeNCT00005567
Parental Knowledge and Beliefs About Infant Sleep Position
A study testing Parental knowledge and beliefs about infant sleep position in people with Sudden Infant Death Syndrome, run by National Center for Research Resources (NCRR).
Trial summary
In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although a number of risk factors have been identified. Sleeping on the stomach has been identified as a major risk for SIDS. Read more about this study
- Who is it for?
- Ages 0 years to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death Syndrome
- What is being tested?
- Parental knowledge and beliefs about infant sleep position
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 0 years to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent of a two-week old infant born in the Well Newborn Nursery at Yale-New Haven Hospital. Infant is brought for well child care at Yale-New Haven Hospital Primary Care Center
Who cannot join
None listed.
About this study
In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although a number of risk factors have been identified. Sleeping on the stomach has been identified as a major risk for SIDS. The rates of SIDS have dropped substantially in countries in which the usual sleep position has changed from the stomach to the side or back. Back sleep has been shown to be the most stable and safest position. The American Academy of Pediatrics now recommends the back sleeping position for all healthy infants. Since the American Academy of Pediatrics began advocating the back sleep position, the incidence of SIDS has decreased by more than 40% in this country. However, the decrease has not been uniform across segments of the population. Black infants continue to have a higher rate of SIDS compared with other groups. This discrepancy could be related to infant sleep position practices. Several studies have shown that infants born to low income, minority, inner-city families were more likely to be placed on the stomach to sleep. Education appears to influence choice of sleep position and may explain, at least to some degree, the difference in choice of sleep position among certain groups. We believe that uniform education of parents will influence the sleep position that parents choose for their baby. We will undertake this initial study to document what parents choose to do with their infants regarding sleep position and why they make these choices so that we can improve our educational approach.
- Conditions
- Sudden Infant Death Syndrome
- Being tested
- Parental knowledge and beliefs about infant sleep position
- 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.
Parental knowledge and beliefs about infant sleep positionBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2000 (estimated)
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.
- 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
- Early clinical test
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005567
- Sponsor's protocol ID
- NCRR-M01RR06022-0038
- Other IDs
- M01RR006022
- Status last verified
- Apr 2000
- First submitted
- 22 Apr 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Knowledge and Beliefs About Infant Sleep Position
- ClinicalTrials.gov ID
- NCT00005567
- Acronym / sponsor ID
- NCRR-M01RR06022-0038
- Conditions
- Sudden Infant Death Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 24 Apr 2000 (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.
In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although a number of risk factors have been identified. Sleeping on the stomach has been identified as a major risk for SIDS. The rates of SIDS have dropped substantially in countries in which the usual sleep position has changed from the stomach to the side or back. Back sleep has been shown to be the most stable and safest position. The American Academy of Pediatrics now recommends the back sleeping position for all healthy infants. Since the American Academy of Pediatrics began advocating the back sleep position, the incidence of SIDS has decreased by more than 40% in this country. However, the decrease has not been uniform across segments of the population. Black infants continue to have a higher rate of SIDS compared with other groups. This discrepancy could be related to infant sleep position practices. Several studies have shown that infants born to low income, minority, inner-city families were more likely to be placed on the stomach to sleep. Education appears to influence choice of sleep position and may explain, at least to some degree, the difference in choice of sleep position among certain groups. We believe that uniform education of parents will influence the sleep position that parents choose for their baby. We will undertake this initial study to document what parents choose to do with their infants regarding sleep position and why they make these choices so that we can improve our educational approach.
Study design
- Primary purpose
- Early clinical test
Who may qualify
- Ages
- 0 years to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parent of a two-week old infant born in the Well Newborn Nursery at Yale-New Haven Hospital. Infant is brought for well child care at Yale-New Haven Hospital Primary Care Center
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Parental knowledge and beliefs about infant sleep position | Behavioural | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Parental knowledge and beliefs about infant sleep position in people with Sudden Infant Death Syndrome, run by National Center for Research Resources (NCRR).
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 0 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
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 24 Jun 2005.