MedTrace Logo

Identifying the Relative Change in Ventilation in Newborns With Placement in Car Bed or Car Seat

NCT00382876 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2006-10-17

No results posted yet for this study

Summary

The infant car restraint devices are a critical part of infant safety during transportation. The crash tolerance and the critical safety features of each seat are well established. Infant transportation may be via a car seat or car bed. The effect of the sitting position on the airway is a concern in an infant with poor head control. Because of this concern, car seat tests during which oxygen saturation is measured, are performed on many low birth weight infants before discharge from the nursery. Indeed, a number of deaths have occurred in car seats probably related to airway obstruction. The relative effects of position on the ventilation need to be established.

We propose to identify the relative changes in ventilation that are induced by position change during sleep. We will collect a broad array of high quality data that will identify these changes, and the most likely cause. Specifically, we will we screen 200 infants, with each infant assigned to the supine position, the car bed and the car seat. The order of these positions will be randomly assigned. Following data will be collected:

1. Relative changes in ventilation will be assessed by oxygen saturation measurement.
2. Respiratory movement will be measured in order to define the defect.
3. Once the data is collected, it will be sent for blind data analysis.
4. Once the data analysis is complete, the effect of position on ventilation will be established.

Conditions

  • Apnea

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Bernard Kinane, MB · Harvard Medical School (HMS and HSDM)

Eligibility

Min Age
1 Day
Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30

Countries

  • Slovenia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00382876 on ClinicalTrials.gov