Airway Pressure During Nasal High Flow and CPAP in Neonates

October 29, 2019 updated by: Research Center of Maternal and Child Health Protection, Armenia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia, 0002
        • Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health
      • Yerevan, Armenia, 0002
        • RCMCHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy term newborns

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NHF small cannula
NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow)
Device: NHF small cannula
NHF 8 l/min by Airvo 2 by small cannula
Other Names:
  • Optiflow, HFNC
Experimental: NHF big cannula
NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple)
Device: NHF big cannula
NHF 8 l/min by Airvo 2 by large cannula
Other Names:
  • Optiflow, HFNC
Experimental: Mask CPAP
CPAP 5cm H2O
Device: CPAP
Nsal CPAP 5cm H2o by face mask
No Intervention: no intervention
control

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Center of Maternal and Child Health Protection, Armenia

Collaborators

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Pavel Mazmanyan, MD PhD, Research Center of Maternal and Child Health Protection, Armenia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

October 31, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCMCHP012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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