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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by King Fahad Medical City.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
King Fahad Medical City
ClinicalTrials.gov Identifier:
NCT00850902
First received: February 23, 2009
Last updated: March 9, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850902

Contacts
Contact: Jasim Anabrees +966 590 591 102 jasim1800@yahoo.com

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

No publications provided

Responsible Party: Jasim Anabrees, King Fahad Medical City
ClinicalTrials.gov Identifier: NCT00850902     History of Changes
Other Study ID Numbers: 08-049
Study First Received: February 23, 2009
Last Updated: March 9, 2009
Health Authority: Saudi Arabia: KFMC-Institutional Review Board

Keywords provided by King Fahad Medical City:
ELBW
Humidity
BPD

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014