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

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ClinicalTrials.gov Identifier: NCT02200900
Recruitment Status : Unknown
Verified July 2014 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Extreme Prematurity - Less Than 28 Weeks Respiratory Distress Syndrome in Premature Infants Other: Pharyngeal pressure Other: Transcutaneous carbon dioxide Other: Pharyngeal gas concentrations Other: Tidal volume Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Nasopharyngeal Pressures, Tidal Breathing Indices and Inspired Gas Concentrations During High Flow Nasal Cannula (HFNC) and CPAP Treatment in Neonates
Study Start Date : August 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015


Arm Intervention/treatment
Active Comparator: Group 1 ( CPAP followed by HFNC)
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
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.

Active Comparator: Group 2 (HFNC followed by CPAP)
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
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.




Primary Outcome Measures :
  1. Nasopharyngeal pressures (pressures in upper breathing passages) generated by HFNC at flow rate range of 2 to 8 L/min. [ Time Frame: Primary outcome recorded during the measurement period of 2 hours. ]
    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.


Secondary Outcome Measures :
  1. Nasopharyngeal pressures (pressures in upper breathing passages) generated at CPAP of 6 cm of water [ Time Frame: Pressures recorded during the study period of 2 hours ]
    The nasopharyngeal pressures recorded during CPAP of 6 cm of water pressure will be documented.

  2. 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. [ Time Frame: Recorded during the study period of 2 hours ]
    The physiological parameters including oxygen saturation and transcutaneous CO2, Respiratory rate, Tidal volume and Functional Residual Capacity (FRC) baseline change will be recorded by monitors during the study period.

  3. The relationship of flow and inspired oxygen concentration on actual laryngeal inspired and expired O2 and CO2 concentration in HFNC and CPAP. [ Time Frame: Recorded during the 2 hour study period ]
    The relationship of flow and inspired oxygen concentration on actual pharyngeal inspired and expired O2 and CO2 concentration in HFNC and CPAP will be noted by gas analyser.



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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by attending neonatology consultant clinician.
  • Participation in a concurrent study that prohibits inclusion in other trials
  • Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
  • Current complications such as pneumothorax.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200900


Contacts
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Contact: Christopher O'Brien, MRCP, FRCPCH 0044-191-2825089 christopher.o'brien@nuth.nhs.uk
Contact: Saikiran Gopalakaje, MD, MRCPCH 0044-191-2821614 saikiran.gopalakaje@nuth.nhs.uk

Locations
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United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
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Principal Investigator: Christopher O'Brien, MRCP, FRCPCH The Newcastle upon Tyne Hospitals NHS Foundation NHS Trust

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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02200900     History of Changes
Other Study ID Numbers: 7022
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
High flow nasal cannula
Continuous Positive Airway Pressure
Respiratory physiology
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases