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

Genetics Home Reference related topics:   Developmental Disabilities  

MedlinePlus related topics:   Hypoglycemia   Hypothermia  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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    
Contact: Iris Morag, MD     972-52-666-7393     irismorag@gmail.com    
Contact: Lidia Gavis, MD     052-666-7360     lidia.gavis@health.gov.il    
Israel
Sheba Medical Center     Not yet recruiting
      Tel Hashomer, Israel, 52621
      Principal Investigator: Iris Morag, MD            
Sheba Medical Center
Principal Investigator:     Iris Morag, M.D     Sheba Medical Center    
  More Information

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

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

Study placed in the following topic categories:
Signs and Symptoms
Hypothermia
Metabolic Diseases
Hyperbilirubinemia
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Jaundice

Additional relevant MeSH terms:
Skin Manifestations
Pathologic Processes
Body Temperature Changes
Hypoglycemia

Source: National Library of Medicine (NLM) July 07, 2008

  


 
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