Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange in Healthy Newborns

Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange During Wakefulness and Sleep in Healthy Newborn Babies in a Randomized Crossover Study Design

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Support
• Intervention / Treatment: Device: Nasal High Flow

Detailed Description

The aim of the study to investigate the effects of NHF therapy on ventilation and gas exchange during wakefulness and sleep in healthy term newborns.

Interventions:

NHF will be applied at 8 L/min (AIRVO 2) via (OPT 316) Optiflow nasal cannula interface without supplemental oxygen. Participants will act as their own control (no intervention) in a randomized crossover study design.

Physiological measurements:

1. Ventilation will be assessed using Respiratory Inductance Plethysmography (RIP) (Respitrace QDC, Viasys, USA).
2. Blood carbon dioxide (CO2) and oxygen levels will be measured by a non-invasive transcutaneous monitor (Tosca, Radiometer, Demnark).
3. All experiment will be recorded using Analogue-to-Digital converter (Powerlab, ADInstruments, New Zealand) and LabChart software with video recording of the patient.
4. Sleep/awake statuss will be determined by videorecording of the patient and Electroencephalogram (EEG) (Alice Polysomnography System Philips, USA)
5. The total study time will be <3 hours in total for each participant. Routine measurement of heart rate, respiratory rate and oxygen saturation will be performed as per standard neonatal clinical practice.
6. Intervention can be terminated if at any time SpO2 drops below 80%, TcCO2 increases above 60 mm Hg, Respiratory Rate increases above 80 breaths per min for more than one minute).

The researcher is an experienced neonatal consultant will be conducting the research and observing the baby throughout the study.

Protocol:

Both control and NHF intervention periods will last a maximum of 40 min each. The maximum duration of the study including set-up, calibration, intervention, washout ans control will be <3 hours. At the beginning of the study when all probes are attached a self-calibration period of RIP will be followed by a calibration of breathing volume with a pneumotachometer attached to a nasal mask. After all calibrations are completed a baseline measurement will be followed by either NHF 8 L/min or a control period without NHF. At the end of this period the interventions will be changes either to control or NHF, which will follow by a washout period (no NHF) and an additional calibration of RIP with a pneumotachometer.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nasal High Flow; NHF will be applied at 8 L/min (AIRVO 2) through (OPT 316) Optiflow nasal cannula interface without supplemental oxygen	Device: Nasal High Flow; Nasal High Flow Therapy
NO_INTERVENTION: Control; Control is no NHF intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue carbon dioxide	Change of transcutaneous tissue carbon dioxide	Up to 1 hour
Tissue oxygen	Change of transcutaneous oxygen	Up to 1 hour
Oxygen saturation	SpO2	Up to 1 hour
Heart rate	Heart rate measured with pulseoximeter	Up to 1 hour

Collaborators and Investigators

• Sponsor: Research Center of Maternal and Child Health Protection, Armenia
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Pavel Mazmanyan, MD, PhD, Head of Neonatal Unit of Research Centre of Maternal and Child Health

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: September 10, 2015
• First Submitted That Met QC Criteria: December 16, 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: newborn; gas exchange; Nasal High Flow
• Other Study ID Numbers: RCMCHP014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO