High Flow Nasal Cannula in Comparison With Nasal Continuo... | NCT02587832

Studies
High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome

NCT02587832

Sponsor

Sidra Medicine

Status

Completed

Last Update Posted

Oct 27, 2015Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Respiratory Distress Syndrome

Interventions

HHHFNC
NCPAP

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

Oct 2015

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

Jul 2009

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Oct 20, 2015

First Submission Date that Met QC Criteria

Oct 25, 2015

First Posted Date

Oct 27, 2015Estimated

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

Oct 25, 2015

Last Update Posted Date

Oct 27, 2015Estimated

Name	Class
Akron Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

To compare the primary outcome, failure of extubation defined by the need for re-intubation and mechanical ventilation within 5 days of initial extubation and secondary outcomes, morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.

Detailed Description

Inclusion criteria were: 1) Preterm neonates with gestational age of 24 to 28 completed weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3) Success to wean with 24 hours to extubate. 4) Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

Exclusion criteria were: 1) Evidence of severe birth asphyxia. 2) Known genetic or chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity. 5) Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Randomization A computer-generated block-randomization sequence with random block sizes was used. Infants who were part of multiple births underwent individual randomization. Clinicians opened consecutively numbered, sealed, brown envelopes immediately before extubation to determine the study-group assignment.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HHHFNC	Active Comparator	Randomized to HHHFNC	Device: HHHFNC
NCPAP	Active Comparator	Randomized to NCPAP	Device: NCPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HHHFNC	Device	Tri-Anim Vaptherm the Precision Flow, which is a self contained unit that provides flow rates up to or 8 LPM (Infants) of blended oxygen that is heated and humidified

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the need for re-intubation	The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation.	5 DAYS

Secondary Outcomes

Measure	Description	Time Frame
Duration of respiratory support using HHHFNC /NCPAP.		through study completion, an average of 1 year.
Incidence of nasal breakdown		through study completion, an average of 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm neonates with gestational age of 24 to 28 completed weeks.
In the case of twins, both neonates were included in the same treatment arm.
Success to wean with 24 hours to extubate.
Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

Exclusion Criteria:

Evidence of severe birth asphyxia.
Known genetic or chromosomal disorders.
Infants delivered to mothers with ruptured membranes of more than three weeks duration.
Potentially life-threatening conditions unrelated to prematurity.
Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

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

Not provided

Overall Officials

Name	Affiliation	Role
Mohammed Elkhwad, MD	Akron Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akron Children's Hospital		Akron	Ohio	44308	United States

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
C564247	Microcephaly, Primary Autosomal Recessive, 6

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided