CompletedNot Applicable

Environmental and Behavioral Risk Factors for Childhood Drowning

United States1,430 participantsStarted 2003-03-17

Plain-language 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. 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.

Who can participate

Age range

1 Year – 20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA - CASES: 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. EXCLUSION CRITERIA - CASES: 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. INCLUSION CRITERIA - CONTROLS: 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00341289

SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2007-01-10

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