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

March 9, 2009 updated by: King Fahad Medical City

Application of a Different Incubator Humidity Strategy at Birth to Decrease Morbidity and Mortality in Extremely Low Birth (1000 g or Less) Infants

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moderate Humidity (MH)
Other: Moderate Humidity
Moderate Humidity Level
Experimental: High Humidity
Other: High Humidity (HH)
High Humidity Level

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Fahad Medical City

Investigators

  • Principal Investigator: Jasim Anabrees, King Fahad Medical City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

March 10, 2009

Last Update Submitted That Met QC Criteria

March 9, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Extremely Low Birth Weight

Clinical Trials on Moderate Humidity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe