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

Extremely Low Birth Weight Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00850902
• Other study ID #: 08-049
• Status: Not yet recruiting
• Phase: N/A
• First received: February 23, 2009
• Last updated: March 9, 2009
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: March 2009
• Source: King Fahad Medical City
• Contact: Jasim Anabrees
• Phone: +966 590 591 102
• Email: jasim1800[@]yahoo.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: KFMC-Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Extremely Low Birth Weight

Intervention

Other:
• High Humidity (HH)
High Humidity Level
• Moderate Humidity
Moderate Humidity Level

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Medical City

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age.		36 weeks postmenstrual age	No