Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341289
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Environmental and Behavioral Risk Factors for Childhood Drowning
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Environmental and Behavioral Risk Factors for Childhood Drowning
Status:
COMPLETED
Status Verified Date:
2009-09-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studys 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 childs 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 childs 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 childs risk-taking and sensation-seeking behaviors Information on additional risk factors such as the remoteness of the site of the drowning and the victims 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
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 childs 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 childs 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 childs risk-taking and sensation-seeking behaviors Information on additional risk factors such as the remoteness of the site of the drowning and the victims 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 parentsguardians 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 examinerscoroners MEC As part of the investigation of drowning deaths investigators from the medical examinerscoroners 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 MECs 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 MEC office will introduce the current study to the parentguardian 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
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 parentsguardians 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 examinerscoroners MEC As part of the investigation of drowning deaths investigators from the medical examinerscoroners 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 MECs 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 MEC office will introduce the current study to the parentguardian 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-CH-N141 | None | None | None |