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

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00550069
Collaborator
(none)
300
Enrollment
1
Location
13
Duration (Months)
23
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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
    Anticipated 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 :
    Dec 1, 2007
    Anticipated Study Completion Date :
    Jan 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Hour to 30 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Gestational age 34wks- 37wks

    • Singleton

    • Without chromosomal abnormalities or malformations

    Exclusion Criteria:

    • No chromosomal abnormalities

    • Malformations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Tel Hashomer Israel 52621

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Principal Investigator: Iris Morag, M.D, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00550069
    Other Study ID Numbers:
    • SHEBA-07-4821-IM-CTIL
    First Posted:
    Oct 26, 2007
    Last Update Posted:
    Dec 27, 2007
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    late preterm infants
    near term infants
    outcome
    Additional relevant MeSH terms:
    Hypoglycemia
    Hypothermia
    Jaundice

    Study Results

    No Results Posted as of Dec 27, 2007