Level of Continuous Positive Airway Pressure (CPAP) in Pr... | NCT00636324

Studies
Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)

NCT00636324

Sponsor

Hamilton Health Sciences Corporation

Status

Terminated

Last Update Posted

Feb 10, 2009Estimated

Enrollment

23Actual

Phase

Phase 2

Conditions

Respiratory Insufficiency of Prematurity

Interventions

Nasal CPAP, level 7 to 9 cmH2O
Nasal CPAP, level 4 to 6 cmH2O

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties in recruitment - will require longer time to achieve sample size

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Jun 2010Estimated

First Submitted Date

Mar 7, 2008

First Submission Date that Met QC Criteria

Mar 13, 2008

First Posted Date

Mar 14, 2008Estimated

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

Feb 9, 2009

Last Update Posted Date

Feb 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

Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its application remain. Clinical indications vary greatly between institutions, especially when combined with varieties of systems, devices, and techniques available. One of the controversial aspects that needs to be clarified is the level of pressure which should be used. The objective of the study is to compare the effectiveness of two ranges of nCPAP pressure that are within the spectrum of current practice for post-extubation support in very preterm infants.

Detailed Description

The use of nCPAP has been established as an effective respiratory support to prevent extubation failure and as treatment of other pulmonary diseases. An upsurge in its popularity has resulted in some controversial aspects, including the level of pressure to be used. The level that has been used in very preterm infants after extubation, which mostly came from anecdotal data, varies from 3 to 10 cmH2O.

Physiologic studies show higher nCPAP pressures improve lung mechanical properties. Though potential side effects have been of concern in practical application, there is no formal evidence supporting the concept that increased CPAP pressure results in a higher risk of complications. In relatively stable preterm infants, the range of optimal CPAP level needs to be established in order to adequately support the upper airway and lungs, without increasing complications secondary to the pressure applied. Given the uncertainty of the nCPAP pressure that should be used in very preterm infants, we conduct a randomized controlled trial to compare the effectiveness of two ranges of nCPAP pressure for post-extubation support in very preterm infants.

The purpose of this trial is to compare the rate of successful extubation of using the nasal CPAP level of 7 to 9 cmH2O compared to level of 4 to 6 cmH2O.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Nasal CPAP, level of 7 to 9 cmH2O	Device: Nasal CPAP, level 7 to 9 cmH2O
2	Active Comparator	Nasal CPAP, level 4 to 6 cmH2O	Device: Nasal CPAP, level 4 to 6 cmH2O

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasal CPAP, level 7 to 9 cmH2O	Device	Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of successful extubation within 72 hours of extubation		within 72 hours after extubation

Secondary Outcomes

Measure	Description	Time Frame
The rate of successful extubation within 7 days of extubation		within 14 days after extubation
Number of days on nCPAP		within 14 days after extubation
Occurrence of air leak syndrome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Birth weight 500 - 1,250 g
On mechanical ventilation before 7 days of age
First extubation before 14 days of age

Exclusion Criteria:

Presence of lethal anomalies or upper airway abnormalities
IVH, grade 3 or 4
Neuromuscular disorders
Receiving muscle relaxation at time of extubation
Congenital heart disease, except for PDA
GI problems resulting in a need to avoid gastric distension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giulherme M SantAnna, MD	Hamilton Health Sciences Corporation	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D012128	Respiratory Distress Syndrome
D011030	Pneumothorax
D055370	Lung Injury

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D008171	Lung Diseases
D010995	Pleural Diseases

Browse Leaves

Not provided

Browse Branches

Not provided