Observational Crossover Study Comparing Oxygenation and V... | NCT01053455

Studies
Observational Crossover Study Comparing Oxygenation and Ventilation Using SiPAP Versus CPAP in LBW Infants

NCT01053455

Sponsor

Children's Hospitals and Clinics of Minnesota

Status

Completed

Last Update Posted

Jun 22, 2012Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Ventilation
Respiratory Distress Syndrome

Interventions

SiPAP

Countries

United States

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jan 20, 2010

First Submission Date that Met QC Criteria

Jan 20, 2010

First Posted Date

Jan 21, 2010Estimated

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

Jun 21, 2012

Last Update Posted Date

Jun 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Lampland, Neonatologist, Children's Hospitals and Clinics of MinnesotaPrincipal Investigator

Lead Sponsor

Children's Hospitals and Clinics of MinnesotaOTHER

Collaborators

Not provided

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

Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Starting on NCPAP		randomized to start on NCPAP	Device: SiPAP
Starting on SiPAP		randomized to SiPAP	Device: SiPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SiPAP	Device	biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP	Starting on NCPAP Starting on SiPAP

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

LBW infant (birth weight <2500 grams)
Currently on nasal CPAP
Use of nasal CPAP for >24 hours prior to study initiation
If history of intubation with mechanical ventilation, patient will be extubated >24 hours prior to study initiation
FiO2 requirement of 25-50%

Exclusion Criteria:

FiO2 requirement >0.5
Congenital defects/deformities of the head, pulmonary or cardiovascular systems
Chromosomal abnormalities/genetic syndromes
Active medical treatment for symptomatic PDA
Active medical treatment for culture proven sepsis
Within 24 hours of invasive surgical procedure

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

low birth weight infants

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Lampland, MD	Childrens Hospitals and Clinics of MN - St. Paul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Hospital and Clinics of MN - St. Paul		Saint Paul	Minnesota	55102	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25085943	Derived	Lampland AL, Plumm B, Worwa C, Meyers P, Mammel MC. Bi-level CPAP does not improve gas exchange when compared with conventional CPAP for the treatment of neonates recovering from respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F31-4. doi: 10.1136/fetalneonatal-2013-305665. Epub 2014 Aug 1.

ID	Term
D053120	Respiratory Aspiration
D012128	Respiratory Distress Syndrome

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms