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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 because the information has not been verified recently.
Verified December 2007 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00550069
First received: October 25, 2007
Last updated: December 24, 2007
Last verified: December 2007
History of Changes
  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.

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Iris Morag, Sheba Medical Cener
ClinicalTrials.gov Identifier: NCT00550069     History of Changes
Other Study ID Numbers: SHEBA-07-4821-IM-CTIL
Study First Received: October 25, 2007
Last Updated: December 24, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 23, 2013