DrowningNCT00341289
Environmental and Behavioral Risk Factors for Childhood Drowning
An observational study of Drowning, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study will examine the relationship between swimming lessons, swimming ability, and other risk factors or protective factors, and the risk of drowning among children. The study's primary focus is on children between 1 and 4 years of age, with a secondary focus on older children up to 19 years of age. Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Drowning
- How many people
- 1,430 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2003to 10 Jan 2007
- Phase
- Observational
- 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 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Drowning in which the submersion event occurred during the study period. Drowning is defined as death from asphyxia due to submersion in a liquid medium.
- Age: Greater than or equal to 12 months and less than 20 years at the time of the event.
- Site of submersion: Open body of water (such as a pool, Jacuzzi, hot tub, pond, lake, river, canal, quarry, irrigation ditch, dam, or ocean).
- Place of residence: Cases and their parent/guardian must be residents of the United States.
- Controls will be children, who have not experienced a serious submersion event (as defined above), and who reside in the same geographic area as cases.
- Greater than or equal to 12 months and less than 20 years on the reference date (date of submersion for matched case).
- Place of residence: Controls and their parent/guardian must reside in the United States and will be matched to cases by county of residence.
Who cannot join
- Ice Water Submersions, submersions that are intentional or suspected of being intentional, motor vehicle related drownings, submersions in bathtubs, toilets, sinks, or buckets.
- For bodies of water that do not easily fit into the above categories, inclusion will be restricted to bodies of water where swimming ability might be related to the risk of drowning.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, 20892
About this study
This study will examine the relationship between swimming lessons, swimming ability, and other risk factors or protective factors, and the risk of drowning among children. The study's primary focus is on children between 1 and 4 years of age, with a secondary focus on older children up to 19 years of age. Drowning is the second leading cause of accidental death among children under 5 years of age, with drowning rates peaking among 1- to 2- year-olds.
The study will examine the circumstances of cases of children between 1 and 19 years of age who have drowned in a body of water where swimming ability might have been a risk factor, such as a pool, Jacuzzi, hot tub, pond, lake, river, canal quarry, irrigation ditch, dam, or ocean. (Drowning is defined as death from asphyxia while submerged, or within 24 hours of the submersion.)
Read more
The victims' parents or guardians will be interviewed about their child's general health, temperament, motor development, swimming ability, history of swimming lessons, and exposure to water. In addition, they will be asked about environmental factors related to the child's drowning, such as if a lifeguard was present or if, in the case of a pool drowning, there was a fence around the pool. They will be asked about parental norms regarding child supervision and pool-provider advice regarding swimming instruction. Parents of older children will be asked about their child's risk-taking and sensation-seeking behaviors. Information on additional risk factors, such as the remoteness of the site of the drowning and the victim's blood alcohol level will also be obtained.
The above information will be compared with similar information gathered from parents of control subjects-that is, children who are the same age as the victims and who live in the same geographic area. For adolescent cases, information about swimming in unguarded sites or drinking alcoholic beverages while in or around water will be obtained from direct interviews with adolescents, as parents may not have accurate information in these areas.
The information gained from this study will provide guidance for the development of interventions to prevent childhood drowning.
Read the detailed description
Drowning is the second leading cause of unintentional injury death among children in the United States. Children under five years of age are at particularly increased risk with drowning rates peaking among 1-2 year olds. While some preventive strategies, such as pool fencing, are known to be effective, the impact of other preventive strategies is unclear. For example, data regarding the relationship between swimming lessons or swimming ability and the risk of drowning are lacking, making it difficult to formulate guidelines and policies about enrollment of young children in swimming lessons. Information about risk and protective factors for childhood drownings will provide valuable guidance for the design of future interventions to prevent these tragic deaths.
This study utilizes a case-control design to evaluate the relationship between swimming lessons, swimming ability, and other risk or protective factors on the one hand, and the risk of drowning on the other. The primary study hypothesis addresses the relationship between swimming lessons and the risk of drowning among children ages 1 to 4 years, while secondary hypotheses address risk and protective factors for drowning among older children. Parents or guardians of drowning victims and parents/guardians of age-matched controls will be interviewed. A short interview will also be conducted with adolescent controls, aged 14-19 years. Interviews include questions regarding exposure to water, swimming ability, participation in swimming lessons, and a number of other factors that might influence the risk of drowning.
Cases will be identified through a consortium of medical examiners/coroners (ME/C). As part of the investigation of drowning deaths, investigators from the medical examiners/coroners' offices routinely collect information about the circumstances surrounding the death; however, the format and content varies somewhat with jurisdiction. In the first phase of the proposed study a consortium of ME/C's will be assembled and a short abstract form will be developed to standardize collection of information relevant to the investigation. At the conclusion of the routine investigation, the investigator from ME/C office will introduce the current study to the parent/guardian. Case families, who have not indicated a refusal for a telephone interview, will be contacted by study staff for a more in-depth interview. Random digit dialing (RDD) will be used to identify appropriately matched control children. Study interviews will be conducted by telephone.
- Conditions
- Drowning
- Keywords
- Submersion, Epidemiology, Fatal, Child, Swim, Drowning, Survey
- Medical subject headings
- Drowning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start17 Mar 2003
- Primary completion10 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DrowningStudies 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
- Observational
- Enrolment
- 1,430 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341289
- Sponsor's protocol ID
- 999903141
- Other IDs
- 03-CH-N141
- Status last verified
- 2 Sep 2009
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Gulaid JA, Sattin RW. Drownings in the United States, 1978-1984. MMWR CDC Surveill Summ. 1988 Feb;37(1):27-33. No abstract available.
PubMed 3127683Quan L, Gore EJ, Wentz K, Allen J, Novack AH. Ten-year study of pediatric drownings and near-drownings in King County, Washington: lessons in injury prevention. Pediatrics. 1989 Jun;83(6):1035-40.
PubMed 2726330Wintemute GJ. Childhood drowning and near-drowning in the United States. Am J Dis Child. 1990 Jun;144(6):663-9. doi: 10.1001/archpedi.1990.02150300061018.
PubMed 2189297
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental and Behavioral Risk Factors for Childhood Drowning
- ClinicalTrials.gov ID
- NCT00341289
- Acronym / sponsor ID
- 999903141
- Conditions
- Drowning
- Keywords
- Submersion, Epidemiology, Fatal, Child, Swim, Drowning, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,430 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 17 Mar 2003
- Primary completion
- 10 Jan 2007 (actual)
- First posted
- 21 Jun 2006 (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 study will examine the relationship between swimming lessons, swimming ability, and other risk factors or protective factors, and the risk of drowning among children. The study's primary focus is on children between 1 and 4 years of age, with a secondary focus on older children up to 19 years of age. Drowning is the second leading cause of accidental death among children under 5 years of age, with drowning rates peaking among 1- to 2- year-olds.
The study will examine the circumstances of cases of children between 1 and 19 years of age who have drowned in a body of water where swimming ability might have been a risk factor, such as a pool, Jacuzzi, hot tub, pond, lake, river, canal quarry, irrigation ditch, dam, or ocean. (Drowning is defined as death from asphyxia while submerged, or within 24 hours of the submersion.)
The victims' parents or guardians will be interviewed about their child's general health, temperament, motor development, swimming ability, history of swimming lessons, and exposure to water. In addition, they will be asked about environmental factors related to the child's drowning, such as if a lifeguard was present or if, in the case of a pool drowning, there was a fence around the pool. They will be asked about parental norms regarding child supervision and pool-provider advice regarding swimming instruction. Parents of older children will be asked about their child's risk-taking and sensation-seeking behaviors. Information on additional risk factors, such as the remoteness of the site of the drowning and the victim's blood alcohol level will also be obtained.
The above information will be compared with similar information gathered from parents of control subjects-that is, children who are the same age as the victims and who live in the same geographic area. For adolescent cases, information about swimming in unguarded sites or drinking alcoholic beverages while in or around water will be obtained from direct interviews with adolescents, as parents may not have accurate information in these areas.
The information gained from this study will provide guidance for the development of interventions to prevent childhood drowning.
Detailed description
Drowning is the second leading cause of unintentional injury death among children in the United States. Children under five years of age are at particularly increased risk with drowning rates peaking among 1-2 year olds. While some preventive strategies, such as pool fencing, are known to be effective, the impact of other preventive strategies is unclear. For example, data regarding the relationship between swimming lessons or swimming ability and the risk of drowning are lacking, making it difficult to formulate guidelines and policies about enrollment of young children in swimming lessons. Information about risk and protective factors for childhood drownings will provide valuable guidance for the design of future interventions to prevent these tragic deaths.
This study utilizes a case-control design to evaluate the relationship between swimming lessons, swimming ability, and other risk or protective factors on the one hand, and the risk of drowning on the other. The primary study hypothesis addresses the relationship between swimming lessons and the risk of drowning among children ages 1 to 4 years, while secondary hypotheses address risk and protective factors for drowning among older children. Parents or guardians of drowning victims and parents/guardians of age-matched controls will be interviewed. A short interview will also be conducted with adolescent controls, aged 14-19 years. Interviews include questions regarding exposure to water, swimming ability, participation in swimming lessons, and a number of other factors that might influence the risk of drowning.
Cases will be identified through a consortium of medical examiners/coroners (ME/C). As part of the investigation of drowning deaths, investigators from the medical examiners/coroners' offices routinely collect information about the circumstances surrounding the death; however, the format and content varies somewhat with jurisdiction. In the first phase of the proposed study a consortium of ME/C's will be assembled and a short abstract form will be developed to standardize collection of information relevant to the investigation. At the conclusion of the routine investigation, the investigator from ME/C office will introduce the current study to the parent/guardian. Case families, who have not indicated a refusal for a telephone interview, will be contacted by study staff for a more in-depth interview. Random digit dialing (RDD) will be used to identify appropriately matched control children. Study interviews will be conducted by telephone.
Study design
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Drowning in which the submersion event occurred during the study period. Drowning is defined as death from asphyxia due to submersion in a liquid medium.
- Age: Greater than or equal to 12 months and less than 20 years at the time of the event.
- Site of submersion: Open body of water (such as a pool, Jacuzzi, hot tub, pond, lake, river, canal, quarry, irrigation ditch, dam, or ocean).
- Place of residence: Cases and their parent/guardian must be residents of the United States.
- Controls will be children, who have not experienced a serious submersion event (as defined above), and who reside in the same geographic area as cases.
Key exclusion criteria (2 listed)
- Ice Water Submersions, submersions that are intentional or suspected of being intentional, motor vehicle related drownings, submersions in bathtubs, toilets, sinks, or buckets.
- For bodies of water that do not easily fit into the above categories, inclusion will be restricted to bodies of water where swimming ability might be related to the risk of drowning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 2 Jul 2017.
- Background: PubMed 3127683Gulaid JA, Sattin RW. Drownings in the United States, 1978-1984. MMWR CDC Surveill Summ. 1988 Feb;37(1):27-33. No abstract available.
- Background: PubMed 2726330Quan L, Gore EJ, Wentz K, Allen J, Novack AH. Ten-year study of pediatric drownings and near-drownings in King County, Washington: lessons in injury prevention. Pediatrics. 1989 Jun;83(6):1035-40.
- Background: PubMed 2189297Wintemute GJ. Childhood drowning and near-drowning in the United States. Am J Dis Child. 1990 Jun;144(6):663-9. doi: 10.1001/archpedi.1990.02150300061018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drowning, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 7 inclusion and 2 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341289, which also lists 3 linked publications.
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 2 Jul 2017.