Healia Clinical Trials Information Database

A Prospective Examination of Infant Transition From Car Bed to Car Safety Seat

This research study has been developed to obtain preliminary information about safe timing of the transition of infants from car beds to car seats, and to find out if initial failure of the car seat challenge is associated with small jaw size or increased respiratory illness.

Description

Studies show that car seats can directly reduce injury in motor vehicle accidents. Unfortunately, some premature and term infants have trouble breathing from the semi-upright seating position in car seats. As a result, the American Academy of Pediatrics recommends car seat challenge testing for at-risk infants, including all children born at less than 37 weeks gestation and other high risk newborns such as those with a history of breathing problems and/or low tone. Infants who fail the car seat test are discharged home in car beds. However, guidelines regarding timing of repeat car seat testing or safe transition back to a car seat are currently unavailable.

At present there is no system for continued evaluation of infants sent home in car beds. In addition, it is not known when it is safe to transition infants from their car bed to a car seat. Infants transitioned too early may still have breathing problems and those transitioned too late may be at risk for injury in the event of a crash.

Due to these reasons it is important to find out when it is safe to transition infants from the car bed to a car seat

Moreover, it has recently been shown that some infants with apparent life threatening events (ALTE), have a smaller jaw size than their peers that did not have an ALTE. ALTEs can occur when infants are in their car seats. No studies have been found that looked to see if infants with breathing problems in their car seats also have small jaws. Furthermore no studies have looked to see if infants who fail their initial car seat challenge are at greater risk for respiratory illness during their first year of life.

Status: Active, not recruiting (N/A). Started on April 1st, 2008.

Enrollment: 24 subjects

Study Type: Observational

Study Design:

  • Case-Only
  • Prospective

Conditions:

Interventions:

  • Other: Measure infant's jaw, record all information about car seat testing, and administer questionnaires.

Eligibility

Inclusion Criteria:

  • All infants who visit Children’s Hospital Boston, Center for Healthy Infant Lung Development for follow up car seat testing

Exclusion Criteria:

  • None
Gender

Both

Mininum Age

N/A

Maximum Age

1 Year

Healthy Volunteers

No


Resources

Source: Children's Hospital Boston

Authority: United States: Institutional Review Board

Locations

  • Children's Hosptital, Boston
    Boston
    Massachusetts
    02115
    United States

Officials

None.

Sponsors

  • Children's Hospital Boston (Lead Sponsor)

References

None.

Links

None.


Date Verified
August 1st, 2009
First Received
August 5th, 2009
Last Changed
August 5th, 2009

Information obtained from ClinicalTrials.gov on August 06, 2009. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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