Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal High Flow | Experimental | NHF will be applied at 8 L/min (AIRVO 2) through (OPT 316) Optiflow nasal cannula interface without supplemental oxygen |
|
| Control | No Intervention | Control is no NHF intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal High Flow | Device | Nasal High Flow Therapy |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pavel Mazmanyan, MD, PhD | Head of Neonatal Unit of Research Centre of Maternal and Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health | Yerevan | 0002 | Armenia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxygen saturation | SpO2 | Up to 1 hour |
| Heart rate | Heart rate measured with pulseoximeter | Up to 1 hour |