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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University Medical Centre Ljubljana.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00382876
First received: September 29, 2006
Last updated: October 16, 2006
Last verified: September 2006
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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
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: 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 Medical School
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on November 25, 2014