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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00550069
Other study ID # SHEBA-07-4821-IM-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 25, 2007
Last updated December 24, 2007
Start date December 2007
Est. completion date January 2009

Study information

Verified date December 2007
Source Sheba Medical Center
Contact Iris Morag, MD
Phone +972-52-666-7393
Email irismorag@gmail.com
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date January 2009
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 30 Days
Eligibility Inclusion Criteria:

- Gestational age 34wks- 37wks

- Singleton

- Without chromosomal abnormalities or malformations

Exclusion Criteria:

- No chromosomal abnormalities

- Malformations

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Israel Sheba Medical Center Tel Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life one year No
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