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Identifying the Relative Change in Ventilation in Newborns With Placement in Car Bed or Car Seat
This study is currently recruiting participants.
Verified by University Medical Centre Ljubljana, September 2006
First Received: September 29, 2006   Last Updated: October 16, 2006   History of Changes
Sponsored by: University Medical Centre Ljubljana
Information provided by: University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00382876
  Purpose

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.

Condition
Apnea

U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title: Identifying the Relative Change in Ventilation With Changes in Infant Sleeping Position

Further study details as provided by University Medical Centre Ljubljana:

Estimated Enrollment: 200
Study Start Date: September 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight greater than 2.8 kg
  • Gestation 38-41 weeks
  • Normal newborn examinations
  • Healthy mother

Exclusion Criteria:

  • Weight greater than 4 kg
  • Any abnormality on examination
  • Any medications in mother and child (including insulin; vitamins and folic acid are okay).
  • Caesarean section
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382876

Contacts
Contact: Lilijana Kornhauser Cerar, MD +38615226011 lilijana.kornhauser-cerar@guest.arnes.si
Contact: David Neubauer, MD +38615229090 david.neubauer@mf.uni-lj.si

Locations
Slovenia
Department for Obstetrics, University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, SI-1525
Contact: Lilijana Kornhauser Cerar, MD     +38615226011     lilijana.kornhauser-cerar@guest.arnes.si    
Sub-Investigator: Damjan Osredkar, MD            
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Director: Bernard Kinane, MB Harvard University
  More Information

No publications provided

Study ID Numbers: LKC-01061958
Study First Received: September 29, 2006
Last Updated: October 16, 2006
ClinicalTrials.gov Identifier: NCT00382876     History of Changes
Health Authority: Slovenia: Ministry of Health

Keywords provided by University Medical Centre Ljubljana:
apnea, hypoxia, car seat, car bed

Study placed in the following topic categories:
Apnea

ClinicalTrials.gov processed this record on May 07, 2009