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

Not Applicable

• Conditions: Extremely Low Birth Weight
• Interventions: Other: Moderate Humidity; Other: High Humidity (HH)

• Registration Number: NCT00850902
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Status Verified: 2009-03
• Study Start: 2009-03
• Last Update Submitted: 2009-03-09
• Last Update Posted: 2009-03-10
• Primary Completion: 2010-03
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Humidity (MH)	Moderate Humidity	-
High Humidity	High Humidity (HH)	-

Primary Outcome Measures

Name	Time	Method
Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age.	36 weeks postmenstrual age