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

King Fahad Medical City

Status: Unknown

Conditions: Extremely Low Birth Weight

Treatments: Other: Moderate Humidity; Other: High Humidity (HH)

Study type: Interventional

Funder types: Other

Identifiers

NCT00850902

08-049

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Moderate Humidity (MH)

Active Comparator group

Treatment:

Other: Moderate Humidity

High Humidity

Experimental group

Treatment:

Other: High Humidity (HH)