Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants
Application of a Different Incubator Humidity Strategy at Birth to Decrease Morbidity and Mortality in Extremely Low Birth (1000 g or Less) Infants
1 other identifier
interventional
700
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMarch 10, 2009
March 1, 2009
1 year
February 23, 2009
March 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age.
36 weeks postmenstrual age
Study Arms (2)
Moderate Humidity (MH)
ACTIVE COMPARATORHigh Humidity
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Inborn Premature Infants with weight ≤ 1000 g at birth
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Jasim Anabrees
King Fahad Medical City
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 25, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
March 10, 2009
Record last verified: 2009-03