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

NCT02200900 | Unknown DMC

• 1 other identifier: 7022
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

High flow nasal cannula; Continuous Positive Airway Pressure; Respiratory physiology

Outcome Measures

Primary Outcomes (1)

• Nasopharyngeal pressures (pressures in upper breathing passages) generated by HFNC at flow rate range of 2 to 8 L/min.

  The range of pressures generated during high flow nasal cannula treatment over flow rate range of 2 to 8 litres per minute will be recorded during the study period.

  Primary outcome recorded during the measurement period of 2 hours.

Secondary Outcomes (3)

• Nasopharyngeal pressures (pressures in upper breathing passages) generated at CPAP of 6 cm of water

  Pressures recorded during the study period of 2 hours

• The effect of changing flow rate of HFNC on following physiological parameters Oxygen saturation and transcutaneous CO2, Respiratory rate, Tidal volume and FRC baseline change.

  Recorded during the study period of 2 hours

• The relationship of flow and inspired oxygen concentration on actual laryngeal inspired and expired O2 and CO2 concentration in HFNC and CPAP.

  Recorded during the 2 hour study period

Study Arms (2)

Group 1 ( CPAP followed by HFNC)

ACTIVE COMPARATOR

In this group pharyngeal pressure, transcutaneous carbon dioxide concentration, tidal volumes and pharyngeal gas concentrations will be recorded on CPAP first followed by HFNC.

Other: Pharyngeal pressure; Other: Transcutaneous carbon dioxide; Other: Pharyngeal gas concentrations; Other: Tidal volume

Group 2 (HFNC followed by CPAP)

ACTIVE COMPARATOR

In this group pharyngeal pressure, transcutaneous carbon dioxide concentration, tidal volumes and pharyngeal gas concentrations will be recorded on HFNC first followed by CPAP.

Other: Pharyngeal pressure; Other: Transcutaneous carbon dioxide; Other: Pharyngeal gas concentrations; Other: Tidal volume

Interventions

Pharyngeal pressure OTHER

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

Group 1 ( CPAP followed by HFNC); Group 2 (HFNC followed by CPAP)

Transcutaneous carbon dioxide OTHER

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

Group 1 ( CPAP followed by HFNC); Group 2 (HFNC followed by CPAP)

Pharyngeal gas concentrations OTHER

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

Group 1 ( CPAP followed by HFNC); Group 2 (HFNC followed by CPAP)

Tidal volume OTHER

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

Group 1 ( CPAP followed by HFNC); Group 2 (HFNC followed by CPAP)

Eligibility Criteria

• Age: 5 Days - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• They are less than 37 weeks' gestation at birth and more than 5 days of age
• Are on non-invasive respiratory support and
• The parent(s) have 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 attending neonatology consultant clinician.
• Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
• Current complications such as pneumothorax.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (1)

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants

Interventions

Blood Gas Monitoring, Transcutaneous; Tidal Volume

Intervention Hierarchy (Ancestors)

Oximetry; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Christopher O'Brien, MRCP, FRCPCH

  The Newcastle upon Tyne Hospitals NHS Foundation NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher O'Brien, MRCP, FRCPCH

CONTACT

0044-191-2825089; christopher.o'brien@nuth.nhs.uk

Saikiran Gopalakaje, MD, MRCPCH

CONTACT

0044-191-2821614; saikiran.gopalakaje@nuth.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

GB (1)