Airway Pressure During Nasal High Flow and CPAP in Neonates | NCT02632799

Studies
Airway Pressure During Nasal High Flow and CPAP in Neonates

NCT02632799

Sponsor

Research Center of Maternal and Child Health Protection, Armenia

Status

Completed

Last Update Posted

Oct 31, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Respiratory Insufficiency

Interventions

NHF small cannula
NHF big cannula
CPAP

Countries

Armenia

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 2019

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 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 10, 2015

First Submission Date that Met QC Criteria

Dec 14, 2015

First Posted Date

Dec 17, 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 29, 2019

Last Update Posted Date

Oct 31, 2019Actual

Name	Class
Fisher and Paykel Healthcare	INDUSTRY

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

Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. The aim of the study was to investigate airway pressure during NHF and CPAP in neonates.

Detailed Description

Methods: A physiological study which measured pressure intra-nasally with micro (750 µm) pressure probes (Millar, USA) in 10 (5M / 5F) healthy newborns with mean gestation age 37.18 (SD 1.29) wk and mean birth weight of 2414 (SD 503.13) g. NHF was applied at 8 L/min (AIRVO 2) through smaller (OPT 314) and larger (OPT 316) Optiflow nasal cannula; CPAP 5 cmH20 was produced by a Bubble CPAP system and nasal mask interface at constant flow 8 L/min (Fisher & Paykel Healthcare, NZ). Values are expressed in cmH20 as means and standard deviations (SD).

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NHF small cannula	Experimental	NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow)	Device: NHF small cannula
NHF big cannula	Experimental	NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple)	Device: NHF big cannula
Mask CPAP	Experimental	CPAP 5cm H2O	Device: CPAP
no intervention	No Intervention	control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NHF small cannula	Device	NHF 8 l/min by Airvo 2 by small cannula	NHF small cannula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Upper airway pressure generated by NHF compared to CPAP	Pressure in upper airways	Up to 1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy term newborns

Exclusion Criteria:

Newborns with any medical problems after birth
Absent of parents consents

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

3 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pavel Mazmanyan, MD PhD	Research Center of Maternal and Child Health Protection, Armenia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health		Yerevan		0002	Armenia

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

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Browse Branches

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