Car Seat Transition for At-risk InfantsNCT00953316
Infant Transition From Car Bed to Car Safety Seat
An observational study of Car Seat Transition for At-risk Infants, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Car Seat Transition for At-risk Infants
- What is being tested?
- Measure infant's jaw, record all information about car seat testing, and administer questionnaires.
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 7 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All infants who visit Children's Hospital Boston, Center for Healthy Infant Lung Development for follow up car seat testing
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hosptital, Boston
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Car Seat Transition for At-risk Infants
- Being tested
- Measure infant's jaw, record all information about car seat testing, and administer questionnaires.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Measure infant's jaw, record all information about car seat testing, and administer questionnaires. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startApr 2008
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Car Seat Transition for At-risk InfantsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Rhein, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953316
- Sponsor's protocol ID
- X08-03-0176
- Status last verified
- May 2017
- First submitted
- 5 Aug 2009
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Examination of Infant Transition From Car Bed to Car Safety Seat
- ClinicalTrials.gov ID
- NCT00953316
- Acronym / sponsor ID
- X08-03-0176
- Conditions
- Car Seat Transition for At-risk Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| at-risk infants | – | Other: Measure infant's jaw, record all information about car seat testing, and administer questionnaires.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. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All infants who visit Children's Hospital Boston, Center for Healthy Infant Lung Development for follow up car seat testing
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | at-risk infants |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Car Seat Transition for At-risk Infants, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.