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Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants

Primary Purpose

Extremely Low Birth Weight

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Humidity (HH)
Moderate Humidity
Sponsored by
King Fahad Medical City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Extremely Low Birth Weight focused on measuring ELBW, Humidity, BPD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inborn Premature Infants with weight ≤ 1000 g at birth

Exclusion Criteria:

  • Outborn infants.
  • Failure to obtain parental consent for the study.
  • Congenital malformations likely to affect life expectancy or neurosensory development.
  • Unlikely to be available for follow up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Moderate Humidity (MH)

    High Humidity

    Arm Description

    Outcomes

    Primary Outcome Measures

    Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2009
    Last Updated
    March 9, 2009
    Sponsor
    King Fahad Medical City
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00850902
    Brief Title
    Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants
    Official Title
    Application of a Different Incubator Humidity Strategy at Birth to Decrease Morbidity and Mortality in Extremely Low Birth (1000 g or Less) Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    March 2010 (Anticipated)
    Study Completion Date
    April 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    King Fahad Medical City

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Extremely Low Birth Weight
    Keywords
    ELBW, Humidity, BPD

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    700 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Moderate Humidity (MH)
    Arm Type
    Active Comparator
    Arm Title
    High Humidity
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    High Humidity (HH)
    Intervention Description
    High Humidity Level
    Intervention Type
    Other
    Intervention Name(s)
    Moderate Humidity
    Intervention Description
    Moderate Humidity Level
    Primary Outcome Measure Information:
    Title
    Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age.
    Time Frame
    36 weeks postmenstrual age

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inborn Premature Infants with weight ≤ 1000 g at birth Exclusion Criteria: Outborn infants. Failure to obtain parental consent for the study. Congenital malformations likely to affect life expectancy or neurosensory development. Unlikely to be available for follow up.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jasim Anabrees
    Phone
    +966 590 591 102
    Email
    jasim1800@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jasim Anabrees
    Organizational Affiliation
    King Fahad Medical City
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants

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