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

Respiratory Support Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632825
• Other study ID #: RCMCHP014
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2019
• Source: Research Center of Maternal and Child Health Protection, Armenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Support

Intervention

Device:
• Nasal High Flow
Nasal High Flow Therapy

Locations

Country	Name	City	State
Armenia	Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health	Yerevan

Sponsors (2)

Lead Sponsor	Collaborator
Research Center of Maternal and Child Health Protection, Armenia	Fisher and Paykel Healthcare

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of minute ventilation	Change of minute ventilation measured with calibrated Respiratory Inductance Plethysmography	Up to 1 hour
Primary	Change of respiratory rate	Change of respiratory rate measured with Respiratory Inductance Plethysmography	Up to 1 hour
Secondary	Tissue carbon dioxide	Change of transcutaneous tissue carbon dioxide	Up to 1 hour
Secondary	Tissue oxygen	Change of transcutaneous oxygen	Up to 1 hour
Secondary	Oxygen saturation	SpO2	Up to 1 hour
Secondary	Heart rate	Heart rate measured with pulseoximeter	Up to 1 hour