Infant Transition From Car Bed to Car Safety Seat

NCT00953316 | Completed

• 1 other identifier: X08-03-0176
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Car Seat Transition for At-risk Infants

Study Arms (1)

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.

Interventions

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

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.

at-risk infants

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hosptital, Boston

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: April 1, 2008
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

US (1)