Extreme Prematurity - Less Than 28 WeeksNCT02200900
Study of Respiratory Physiology During High Flow Nasal Cannula Treatment in Preterm Neonates.
A study testing Pharyngeal pressure, Transcutaneous carbon dioxide and Pharyngeal gas concentrations in people with Extreme Prematurity - Less Than 28 Weeks and Respiratory Distress Syndrome in Premature Infants, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 days to 4 months
- Conditions the study is for
- Extreme Prematurity - Less Than 28 Weeks, Respiratory Distress Syndrome in Premature Infants
- What is being tested?
- Pharyngeal pressure, Transcutaneous carbon dioxide and Pharyngeal gas concentrations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 days to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
About this study
Official title: Study of Nasopharyngeal Pressures, Tidal Breathing Indices and Inspired Gas Concentrations During High Flow Nasal Cannula (HFNC) and CPAP Treatment in Neonates
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
Read more
- 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.
Read the detailed description
Purpose and design
Design: Prospective randomised crossover study.
Purpose:
- Raising airway pressure is one of the most important interventions at the disposal of clinicians treating patients with respiratory failure. In premature infants Continuous Positive Airway Pressure (CPAP) and High Flow Nasal Cannula (HFNC) are noninvasive techniques to raise mean airway pressure when intubation is not required. It is not clear how clinicians choose between these techniques and there is little data comparing the physiological effect of these treatments.
- A composite physiological assessment of babies on HFNC and CPAP treatment is required to understand how HFNC works. It is important to answer this question to understand how best to use HFNC in babies.
- This proposal is designed to provide information on physiological effects of both therapies in same population of babies across different weight categories. The study protocol involves use of same HFNC device that is currently being used in neonatal unit.
Interventions:
- A small plastic catheter tip transducer (Gaeltec) will be placed in upper breathing passage (nasopharynx or oropharynx) using standard methods. From this we will measure airway pressures and respiratory gas concentrations.
The catheter will be removed soon after the study is completed. This procedure will be done once during the study.
- Breathing markers (Tidal breathing indices) will be measured by non invasive method using Volusense method where a vest will be applied over the chest and abdomen like a layer of clothing. The Volusense vest will be removed soon after the procedure. This process is done once during the study.
- Blood carbon dioxide (CO2) levels will be measured by a non invasive transcutaneous sensor applied to the skin (Tosca Radiometer). This skin sensor will be removed soon after the study is completed.
- The baby must be clinically stable for preceding 12 hours on noninvasive breathing support (not meeting exit criteria). The babies will be randomised to either group 1 (CPAP first followed by HFNC) or group 2 (HFNC first followed by CPAP) by computerised software programme.
- The measuring devices namely nasopharyngeal catheter, Volusense vest and transcutaneous CO2 sensor are placed as per standard methods.
- After ensuring babies' clinical stability the measurements are recorded at HFNC gas flow rate range from 2 litres to 8 litres per minute and in CPAP of 6 cm of water pressure level.
- The study lasts about 2 hours. The baby spends 10 minutes at each HFNC flow rate level and 30 minutes of equilibration period when support will be changed between HFNC and CPAP.
- Routine measurement of heart rate, respiratory rate and oxygen saturations will be done as per standard neonatal practice. The above data will be recorded electronically for analysis with total study duration around 120 minutes.
- Respiratory support can be terminated at any point if clinically not indicated.
The researcher is an experienced neonatal registrar who will be directly observing the baby throughout the study.
Measurements would be discontinued if any pre set exit criteria is noted.
Statistics: A total of 45 babies (15 babies in each weight category: <1000 grams, 1001500 grams and >1500 grams) will be studied.
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Respiratory Distress Syndrome in Premature Infants
- Being tested
- Pharyngeal pressure, Transcutaneous carbon dioxide, Pharyngeal gas concentrations, Tidal volume
- Keywords
- High flow nasal cannula, Continuous Positive Airway Pressure, Respiratory physiology
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal pressureOther
Babies will have pharyngeal pressures measured during the CPAP and HFNC respiratory support.
Transcutaneous carbon dioxideOther
Babies will have transcutaneous carbon dioxide measured during CPAP and HFNC respiratory support.
Pharyngeal gas concentrationsOther
Measurement of pharyngeal oxygen and carbon dioxide concentration will be done during CPAP and HFNC respiratory support.
Tidal volumeOther
Tidal breathing indices including tidal volume and FRC base line changes will be recorded during CPAP and HFNC respiratory support.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pharyngeal pressure; Other: Transcutaneous carbon dioxide; Other: Pharyngeal gas concentrations; Other: Tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The nasopharyngeal pressures recorded during CPAP of 6 cm of water pressure will be documented.
Measured: 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.
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.
Measured: 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.
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.
Measured: Recorded during the 2 hour study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extreme Prematurity - Less Than 28 WeeksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher O'Brien, MRCP, FRCPCH, Principal investigator, The Newcastle upon Tyne Hospitals NHS Foundation NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200900
- Sponsor's protocol ID
- 7022
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nasopharyngeal Pressures, Tidal Breathing Indices and Inspired Gas Concentrations During High Flow Nasal Cannula (HFNC) and CPAP Treatment in Neonates
- ClinicalTrials.gov ID
- NCT02200900
- Acronym / sponsor ID
- 7022
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Respiratory Distress Syndrome in Premature Infants
- Keywords
- High flow nasal cannula, Continuous Positive Airway Pressure, Respiratory physiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose and design
Design: Prospective randomised crossover study.
Purpose:
- Raising airway pressure is one of the most important interventions at the disposal of clinicians treating patients with respiratory failure. In premature infants Continuous Positive Airway Pressure (CPAP) and High Flow Nasal Cannula (HFNC) are noninvasive techniques to raise mean airway pressure when intubation is not required. It is not clear how clinicians choose between these techniques and there is little data comparing the physiological effect of these treatments.
- A composite physiological assessment of babies on HFNC and CPAP treatment is required to understand how HFNC works. It is important to answer this question to understand how best to use HFNC in babies.
- This proposal is designed to provide information on physiological effects of both therapies in same population of babies across different weight categories. The study protocol involves use of same HFNC device that is currently being used in neonatal unit.
Interventions:
- A small plastic catheter tip transducer (Gaeltec) will be placed in upper breathing passage (nasopharynx or oropharynx) using standard methods. From this we will measure airway pressures and respiratory gas concentrations.
The catheter will be removed soon after the study is completed. This procedure will be done once during the study.
- Breathing markers (Tidal breathing indices) will be measured by non invasive method using Volusense method where a vest will be applied over the chest and abdomen like a layer of clothing. The Volusense vest will be removed soon after the procedure. This process is done once during the study.
- Blood carbon dioxide (CO2) levels will be measured by a non invasive transcutaneous sensor applied to the skin (Tosca Radiometer). This skin sensor will be removed soon after the study is completed.
- The baby must be clinically stable for preceding 12 hours on noninvasive breathing support (not meeting exit criteria). The babies will be randomised to either group 1 (CPAP first followed by HFNC) or group 2 (HFNC first followed by CPAP) by computerised software programme.
- The measuring devices namely nasopharyngeal catheter, Volusense vest and transcutaneous CO2 sensor are placed as per standard methods.
- After ensuring babies' clinical stability the measurements are recorded at HFNC gas flow rate range from 2 litres to 8 litres per minute and in CPAP of 6 cm of water pressure level.
- The study lasts about 2 hours. The baby spends 10 minutes at each HFNC flow rate level and 30 minutes of equilibration period when support will be changed between HFNC and CPAP.
- Routine measurement of heart rate, respiratory rate and oxygen saturations will be done as per standard neonatal practice. The above data will be recorded electronically for analysis with total study duration around 120 minutes.
- Respiratory support can be terminated at any point if clinically not indicated.
The researcher is an experienced neonatal registrar who will be directly observing the baby throughout the study.
Measurements would be discontinued if any pre set exit criteria is noted.
Statistics: A total of 45 babies (15 babies in each weight category: <1000 grams, 1001500 grams and >1500 grams) will be studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 ( CPAP followed by HFNC) | Active comparator | Other: Pharyngeal pressure, Other: Transcutaneous carbon dioxide, Other: Pharyngeal gas concentrations, Other: Tidal volumeIn this group pharyngeal pressure, transcutaneous carbon dioxide concentration, tidal volumes and pharyngeal gas concentrations will be recorded on CPAP first followed by HFNC. |
| Group 2 (HFNC followed by CPAP) | Active comparator | Other: Pharyngeal pressure, Other: Transcutaneous carbon dioxide, Other: Pharyngeal gas concentrations, Other: Tidal volumeIn this group pharyngeal pressure, transcutaneous carbon dioxide concentration, tidal volumes and pharyngeal gas concentrations will be recorded on HFNC first followed by CPAP. |
Who may qualify
- Ages
- 5 days to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharyngeal pressureBabies will have pharyngeal pressures measured during the CPAP and HFNC respiratory support. | Other | Group 1 ( CPAP followed by HFNC), Group 2 (HFNC followed by CPAP) |
| Transcutaneous carbon dioxideBabies will have transcutaneous carbon dioxide measured during CPAP and HFNC respiratory support. | Other | Group 1 ( CPAP followed by HFNC), Group 2 (HFNC followed by CPAP) |
| Pharyngeal gas concentrationsMeasurement of pharyngeal oxygen and carbon dioxide concentration will be done during CPAP and HFNC respiratory support. | Other | Group 1 ( CPAP followed by HFNC), Group 2 (HFNC followed by CPAP) |
| Tidal volumeTidal breathing indices including tidal volume and FRC base line changes will be recorded during CPAP and HFNC respiratory support. | Other | Group 1 ( CPAP followed by HFNC), Group 2 (HFNC followed by CPAP) |
Primary outcome
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.
3 secondary outcomes
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 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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
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Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher O'Brien, MRCP, FRCPCH principal investigator
The Newcastle upon Tyne Hospitals NHS Foundation NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal pressure, Transcutaneous carbon dioxide and Pharyngeal gas concentrations in people with Extreme Prematurity - Less Than 28 Weeks and Respiratory Distress Syndrome in Premature Infants, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher O'Brien, MRCP, FRCPCH (0044-191-2825089, christopher.o'brien@nuth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.