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

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ClinicalTrials.gov Identifier: NCT00550069
Recruitment Status : Unknown
Verified December 2007 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 26, 2007
Last Update Posted : December 27, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease
Respiratory Distress Hypoglycemia Feeding Intolerance Jaundice Hypothermia Developmental Delay

Detailed Description:
The study will include all near term infants born at 3 Israeli medical centers during a one year period.

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
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.
Study Start Date : December 2007
Estimated Study Completion Date : January 2009
Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

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

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

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

Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Iris Morag, MD         
Sponsors and Collaborators
Sheba Medical Center
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 Posted: October 26, 2007    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007

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

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