Study of Respiratory Physiology During High Flow Nasal Cannula Treatment in Preterm Neonates.

Summary

The most commonly used noninvasive respiratory support in preterm babies is Continuous Positive Airway Pressure (CPAP), which provides extra breathing support to babies who are breathing by themselves). Increasingly High flow Nasal Cannula (HFNC, newer form of extra breathing support) therapy has found its way in clinical practice despite lack of good physiological data. There are also concerns about its potential to generate higher pressures in airways which can cause over distension of lungs.

We would like to find out the effects of HFNC on

* 1\. Airway pressures in various flow rates and in comparison to CPAP.
* 2\. Breathing markers including respiratory rate (speed of breathing), oxygen and carbon dioxide levels, tidal volumes (how much air breathed in with each breath) and airway wash out (wash out of waste gas from the airway).

We plan to study 15 babies each in three different weight categories supported with either CPAP or HFNC. The airway pressures, oxygen and carbon dioxide concentration in airway are measured by a small plastic catheter (similar to feeding tube but much shorter in length), carbon dioxide levels by skin sensors, how fast and how much babies breathe by a special vest applied like a layer of clothing. These will be recorded both on HFNC and CPAP. There are no blood tests or invasive procedures involved. The baby will be monitored throughout the study period of approximately two hours by experienced registrar who is trained to use the study device.

This study will improve our understanding of physiological effects of HFNC and lead to better care of preterm babies.

Conditions

• Extreme Prematurity - Less Than 28 Weeks
• Respiratory Distress Syndrome in Premature Infants

Interventions

OTHER

Pharyngeal pressure

Babies will have pharyngeal pressures measured during the CPAP and HFNC respiratory support.

OTHER

Transcutaneous carbon dioxide

Babies will have transcutaneous carbon dioxide measured during CPAP and HFNC respiratory support.

OTHER

Pharyngeal gas concentrations

Measurement of pharyngeal oxygen and carbon dioxide concentration will be done during CPAP and HFNC respiratory support.

OTHER

Tidal volume

Tidal breathing indices including tidal volume and FRC base line changes will be recorded during CPAP and HFNC respiratory support.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Christopher O'Brien, MRCP, FRCPCH · The Newcastle upon Tyne Hospitals NHS Foundation NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

5 Days

Max Age

4 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2015-10-31

Completion

2015-10-31

Countries

• United Kingdom

Study Locations