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Airway Pressure During Nasal High Flow and CPAP in Neonates

Primary Purpose

Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
NHF small cannula
NHF big cannula
CPAP
Sponsored by
Research Center of Maternal and Child Health Protection, Armenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiratory Insufficiency focused on measuring Nasal High Flow, CPAP, airway pressure, newborn

Eligibility Criteria

1 Day - 3 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy term newborns

Exclusion Criteria:

  • Newborns with any medical problems after birth
  • Absent of parents consents

Sites / Locations

  • Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health
  • RCMCHP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

NHF small cannula

NHF big cannula

Mask CPAP

no intervention

Arm Description

NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow)

NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple)

CPAP 5cm H2O

control

Outcomes

Primary Outcome Measures

Upper airway pressure generated by NHF compared to CPAP
Pressure in upper airways

Secondary Outcome Measures

Full Information

First Posted
September 10, 2015
Last Updated
October 29, 2019
Sponsor
Research Center of Maternal and Child Health Protection, Armenia
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02632799
Brief Title
Airway Pressure During Nasal High Flow and CPAP in Neonates
Official Title
Airway Pressure During Nasal High Flow and CPAP in Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Center of Maternal and Child Health Protection, Armenia
Collaborators
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Nasal High Flow, CPAP, airway pressure, newborn

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NHF small cannula
Arm Type
Experimental
Arm Description
NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow)
Arm Title
NHF big cannula
Arm Type
Experimental
Arm Description
NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple)
Arm Title
Mask CPAP
Arm Type
Experimental
Arm Description
CPAP 5cm H2O
Arm Title
no intervention
Arm Type
No Intervention
Arm Description
control
Intervention Type
Device
Intervention Name(s)
NHF small cannula
Other Intervention Name(s)
Optiflow, HFNC
Intervention Description
NHF 8 l/min by Airvo 2 by small cannula
Intervention Type
Device
Intervention Name(s)
NHF big cannula
Other Intervention Name(s)
Optiflow, HFNC
Intervention Description
NHF 8 l/min by Airvo 2 by large cannula
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Nsal CPAP 5cm H2o by face mask
Primary Outcome Measure Information:
Title
Upper airway pressure generated by NHF compared to CPAP
Description
Pressure in upper airways
Time Frame
Up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy term newborns Exclusion Criteria: Newborns with any medical problems after birth Absent of parents consents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Mazmanyan, MD PhD
Organizational Affiliation
Research Center of Maternal and Child Health Protection, Armenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health
City
Yerevan
ZIP/Postal Code
0002
Country
Armenia
Facility Name
RCMCHP
City
Yerevan
ZIP/Postal Code
0002
Country
Armenia

12. IPD Sharing Statement

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Airway Pressure During Nasal High Flow and CPAP in Neonates

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