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

December 24, 2007 updated by: Sheba Medical Center

Late Preterm Infants:Clinical Course and Outcome From Birth Through Out the First Year of Life.

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 month (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All infants born at a gestational age of 34-37 weeks in 3 medical centers in Israel

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No chromosomal abnormalities
  • Malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (ANTICIPATED)

January 1, 2009

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (ESTIMATE)

October 26, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 27, 2007

Last Update Submitted That Met QC Criteria

December 24, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-07-4821-IM-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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