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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00850902
Recruitment Status : Unknown
Verified March 2009 by King Fahad Medical City.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2009
Last Update Posted : March 10, 2009
Information provided by:
King Fahad Medical City

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.

Condition or disease Intervention/treatment Phase
Extremely Low Birth Weight Other: High Humidity (HH) Other: Moderate Humidity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Moderate Humidity (MH) Other: Moderate Humidity
Moderate Humidity Level

Experimental: High Humidity Other: High Humidity (HH)
High Humidity Level

Primary Outcome Measures :
  1. Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age. [ Time Frame: 36 weeks postmenstrual age ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00850902

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Contact: Jasim Anabrees +966 590 591 102

Sponsors and Collaborators
King Fahad Medical City
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Principal Investigator: Jasim Anabrees King Fahad Medical City

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Responsible Party: Jasim Anabrees, King Fahad Medical City Identifier: NCT00850902     History of Changes
Other Study ID Numbers: 08-049
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: March 10, 2009
Last Verified: March 2009
Keywords provided by King Fahad Medical City:
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms