NCT02632799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

September 10, 2015

Last Update Submit

October 29, 2019

Conditions

Respiratory Insufficiency

Keywords

Nasal High FlowCPAPairway pressurenewborn

Outcome Measures

Primary Outcomes (1)

  • Upper airway pressure generated by NHF compared to CPAP

    Pressure in upper airways

    Up to 1 hour

Study Arms (4)

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

NHF small cannulaDEVICE

NHF 8 l/min by Airvo 2 by small cannula

Also known as: Optiflow, HFNC
NHF small cannula
NHF big cannulaDEVICE

NHF 8 l/min by Airvo 2 by large cannula

Also known as: Optiflow, HFNC
NHF big cannula
CPAPDEVICE

Nsal CPAP 5cm H2o by face mask

Mask CPAP

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy term newborns

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Yerevan, 0002, Armenia

Location

RCMCHP

Yerevan, 0002, Armenia

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Pavel Mazmanyan, MD PhD

    Research Center of Maternal and Child Health Protection, Armenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2015

First Posted

December 17, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 31, 2019

Record last verified: 2019-10

Locations

AR(2)