NCT02632825

Brief Summary

Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. It has been shown in adults that NHF produce different effects on ventilation during wakefulness and sleep. There is no physiological data on effects of NHF in neonates. The physiological effects may be impacted by sleep/awake status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months 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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

September 10, 2015

Last Update Submit

October 29, 2019

Conditions

Respiratory Support

Keywords

Nasal High Flowgas exchangenewborn

Outcome Measures

Primary Outcomes (2)

  • Change of minute ventilation

    Change of minute ventilation measured with calibrated Respiratory Inductance Plethysmography

    Up to 1 hour

  • Change of respiratory rate

    Change of respiratory rate measured with Respiratory Inductance Plethysmography

    Up to 1 hour

Secondary Outcomes (4)

  • Tissue carbon dioxide

    Up to 1 hour

  • Tissue oxygen

    Up to 1 hour

  • Oxygen saturation

    Up to 1 hour

  • Heart rate

    Up to 1 hour

Study Arms (2)

Nasal High Flow

EXPERIMENTAL

NHF will be applied at 8 L/min (AIRVO 2) through (OPT 316) Optiflow nasal cannula interface without supplemental oxygen

Device: Nasal High Flow

Control

NO INTERVENTION

Control is no NHF intervention

Interventions

Nasal High FlowDEVICE

Nasal High Flow Therapy

Nasal High Flow

Eligibility Criteria

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

You may qualify if:

  • Healthy full or near full-term newborns of 1-2 days of age.
  • A parent has given written informed consent to their baby's participation.

You may not qualify if:

  • Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician or required supplemental oxygen.
  • Known upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly.
  • A parent has not given written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Yerevan, 0002, Armenia

Location

Study Officials

  • Pavel Mazmanyan, MD, PhD

    Head of Neonatal Unit of Research Centre of Maternal and Child Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 10, 2015

First Posted

December 17, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)