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Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00550069
First Posted: October 26, 2007
Last Update Posted: December 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term). The term "near term infants" is probably a deceiving one.

Condition
Respiratory Distress Hypoglycemia Feeding Intolerance Jaundice Hypothermia Developmental Delay

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Late Preterm Infants:Clinical Course and Outcome From Birth Through Out the First Year of Life.

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life [ Time Frame: one year ]

Estimated Enrollment: 300
Study Start Date: December 2007
Estimated Study Completion Date: January 2009
Detailed Description:
The study will include all near term infants born at 3 Israeli medical centers during a one year period.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All infants born at a gestational age of 34-37 weeks in 3 medical centers in Israel
Criteria

Inclusion Criteria:

  • Gestational age 34wks- 37wks
  • Singleton
  • Without chromosomal abnormalities or malformations

Exclusion Criteria:

  • No chromosomal abnormalities
  • Malformations
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550069


Contacts
Contact: Iris Morag, MD +972-52-666-7393 irismorag@gmail.com
Contact: Lidia Gavis, MD 052-666-7360 lidia.gavis@health.gov.il

Locations
Israel
Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Iris Morag, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Iris Morag, M.D Sheba Medical Center
  More Information

Responsible Party: Dr. Iris Morag, Sheba Medical Cener
ClinicalTrials.gov Identifier: NCT00550069     History of Changes
Other Study ID Numbers: SHEBA-07-4821-IM-CTIL
First Submitted: October 25, 2007
First Posted: October 26, 2007
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Sheba Medical Center:
late preterm infants
near term infants
outcome

Additional relevant MeSH terms:
Hypoglycemia
Hypothermia
Jaundice
Glucose Metabolism Disorders
Metabolic Diseases
Body Temperature Changes
Signs and Symptoms
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations