Infant Transition From Car Bed to Car Safety Seat

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Children's Hospital Boston.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00953316
First received: August 5, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Car Seat Transition for At-risk Infants
Other: Measure infant's jaw, record all information about car seat testing, and administer questionnaires.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Examination of Infant Transition From Car Bed to Car Safety Seat

Further study details as provided by Children's Hospital Boston:

Estimated Enrollment: 24
Study Start Date: April 2008
Groups/Cohorts Assigned Interventions
at-risk infants
Includes 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.
Other: Measure infant's jaw, record all information about car seat testing, and administer questionnaires.
Collect information about car seat testing of infants (until he/she transitions to a car seat), measure the infant's jaw during the first visit using a tape measure 18 different ways by Dr. Rhein or a trained research assistant, and complete a parent questionnaire about car bed use, previous testing of the infant in his/her car seat and information about the infant's home environment such as cigarette smoking, number of other children and daycare arrangements for the infant during the infant's first visit to the clinic. This short questionnaire asks information about car bed use, previous testing of your infant in his/her car seat and information about your home environment such as cigarette smoking, number of other children at your home and daycare arrangements for your infant.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953316

Locations
United States, Massachusetts
Children's Hosptital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Lawrence Rhein, MD, Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT00953316     History of Changes
Other Study ID Numbers: X08-03-0176
Study First Received: August 5, 2009
Last Updated: August 5, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014