Airway Pressure During Nasal High Flow and CPAP in Neonates

NCT ID: NCT02632799

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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).

Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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NHF small cannula

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

Group Type EXPERIMENTAL

NHF small cannula

Intervention Type DEVICE

NHF 8 l/min by Airvo 2 by small cannula

NHF big cannula

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

Group Type EXPERIMENTAL

NHF big cannula

Intervention Type DEVICE

NHF 8 l/min by Airvo 2 by large cannula

Mask CPAP

CPAP 5cm H2O

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

Nsal CPAP 5cm H2o by face mask

no intervention

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NHF small cannula

NHF 8 l/min by Airvo 2 by small cannula

Intervention Type DEVICE

NHF big cannula

NHF 8 l/min by Airvo 2 by large cannula

Intervention Type DEVICE

CPAP

Nsal CPAP 5cm H2o by face mask

Intervention Type DEVICE

Other Intervention Names

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Optiflow, HFNC Optiflow, HFNC

Eligibility Criteria

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Inclusion Criteria

* Healthy term newborns

Exclusion Criteria

* Newborns with any medical problems after birth
* Absent of parents consents
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role collaborator

Research Center of Maternal and Child Health Protection, Armenia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pavel Mazmanyan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Research Center of Maternal and Child Health Protection, Armenia

Locations

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

Yerevan, , Armenia

Site Status

RCMCHP

Yerevan, , Armenia

Site Status

Countries

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Armenia

Other Identifiers

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RCMCHP012

Identifier Type: -

Identifier Source: org_study_id

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