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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by King Fahad Medical City.
Recruitment status was:  Not yet recruiting
Information provided by:
King Fahad Medical City Identifier:
First received: February 23, 2009
Last updated: March 9, 2009
Last verified: March 2009
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 Intervention
Extremely Low Birth Weight Other: High Humidity (HH) Other: Moderate Humidity

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by King Fahad Medical City:

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

Estimated Enrollment: 700
Study Start Date: March 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Moderate Humidity (MH) Other: Moderate Humidity
Moderate Humidity Level
Experimental: High Humidity Other: High Humidity (HH)
High Humidity Level


Ages Eligible for Study:   Child, Adult, Senior
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00850902

Contact: Jasim Anabrees +966 590 591 102

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

Responsible Party: Jasim Anabrees, King Fahad Medical City Identifier: NCT00850902     History of Changes
Other Study ID Numbers: 08-049
Study First Received: February 23, 2009
Last Updated: March 9, 2009

Keywords provided by King Fahad Medical City:

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms processed this record on September 19, 2017