Humidity Strategy to Decrease Morbidity and Mortality in... | NCT00850902

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

NCT00850902

Sponsor

King Fahad Medical City

Status

Unknown status

Last Update Posted

Mar 10, 2009Estimated

Enrollment

700Estimated

Phase

Not Applicable

Conditions

Extremely Low Birth Weight

Interventions

High Humidity (HH)
Moderate Humidity

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Apr 2010Estimated

First Submitted Date

Feb 23, 2009

First Submission Date that Met QC Criteria

Feb 24, 2009

First Posted Date

Feb 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2009

Last Update Posted Date

Mar 10, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Moderate Humidity (MH)	Active Comparator		Other: Moderate Humidity
High Humidity	Experimental		Other: High Humidity (HH)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Humidity (HH)	Other	High Humidity Level	High Humidity
Moderate Humidity

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jasim Anabrees	Contact	+966 590 591 102		jasim1800@yahoo.com

Overall Officials

Name	Affiliation	Role
Jasim Anabrees	King Fahad Medical City	Principal Investigator

Locations

Not provided