Premature BirthNCT01991886
Using Nasal High Flow From Birth in Premature Infants - a Pilot Study
A study testing Vapotherm Precision Flow in people with Premature Birth, run by Ashford and St. Peter's Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Read more about this study
- Who is it for?
- Ages 24 to 30 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Vapotherm Precision Flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Mar 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 24 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parental consent
- 24+0 to 30+0 weeks(agreed dates) gestation born alive
- Breathing spontaneously at birth or soon after with minimal resuscitation
- Oxygen saturations >90% by 5 minutes
Who cannot join
- No parental consent
- Born in poor condition and unlikely to survive
- Needing resuscitation including intubation and/or chest compressions
- Not breathing and thus needing intubation
- Oxygen saturations <90% by 5 minutes
- <24 weeks gestation
- >30 weeks gestation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neonatal ICU, St Peter's Hospital
Chertsey, Surrey, KT16 0PZ
About this study
Official title: A Pilot Study to Determine the Feasibility of the Use of Nasal High Flow From Birth in Premature Infants Born at Less Than or Equal to 30 Week Gestational Age.
Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Those studies showed that even very small babies can be safely supported using nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to breath, albeit with additional support to reduce their work of breathing. However nCPAP has some drawbacks, including that it can cause skin damage to the nose, and that the heating and humidification of the gas is not always sufficient. We have been using, for over 5 years, a different system to support babies after routine intubation. This is another type of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior to nCPAP in respect it does not cause nose damage and its heating and humidification is excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation. This study is important to establish the feasibility of using nHF immediately after birth.
Read the detailed description
We propose to pilot the use of this mobile nHF unit, using the Vapotherm Precision Flow device, in the premature population of babies who would normally be either intubated and given surfactant routinely, or be maintained on nCPAP until arrival on the Neonatal Intensive Care Unit (NICU) then transferred onto nHF. Parents will be informed about the pilot and their permission will be sought. We aim to recruit 40 babies less than 30 weeks gestation.
The reason for undertaking a pilot study of this nature is to establish feasibility and proof of concept. It is not designed to be compared to using nCPAP to stabilise babies immediately after birth (although that will be the next and logical progression if this proves to be a feasible technique).
The hypothesis is that using nHF to stabilise babies immediately after birth will confer the same advantages as using nCPAP to stabilise babies in this way, which has been demonstrated in the worldwide literature. For units such as ours who use nHF in preference to nCPAP, this will be an important step in further defining the management of these babies after birth. There is evidence that nHF is at least as good as nCPAP in preventing intubation and reducing lung disease, and it may also offer additional advantages from humidification and reduction in nasal trauma.
The major challenge for this pilot project will be to identify eligible deliveries in a timely manner to ensure that a suitable member of staff is available to speak to parents and gain consent.
Once a delivery has been identified and the parents have agreed to take part, then the following process will take place to manage the newborn baby.
Check the mobile nHF unit
- The mobile nHF unit should be kept plugged in so that the uninterruptable power supply (UPS) is fully charged
- To use it, unplug it to check that the UPS is functioning (green lights indicate full charge), set up a Vapotherm circuit(as per normal routine) and start the machine running on UPS power supply.
- Gas supply should be from the cylinders to check that the pressures are 50bar in both air and oxygen cylinders
- Set the temperature to 37 degrees Celsius
- Once running, turn the unit off if not immediately needed or plug into the mains power and gas(es) where available to conserve gas. The unit can be run on a flow of 1 litre/minute whilst "ticking over" to conserve cylinder gas if needed.
- The prongs should be attached to the circuit.
Once the baby is born
- Place the baby in a polythene bag (as per normal practice)
- Ensure the baby is breathing. If not, or the baby is bradycardic, then normal resuscitation measures should be applied. It will only be appropriate to apply the mobile nHF if the baby is breathing and is clinically stable.
- Once the baby is born, increase the flow to 6 litres/min
- If the baby is breathing then apply the nHF prongs and observe carefully
- Suction should only be applied gently, if needed to remove excessive secretions in the mouth and throat. Babies on high flow will often "blow bubbles" and there may be lung fluid in the throat, but suction should not be vigorous
- Apply a saturation monitor (as per normal practice) to check Heart Rate (HR) and Oxygen Saturation (SaO2).
- Dry the baby's face sufficiently to be able to apply duoderm dressing to stick down the prongs to the cheeks.
- Observe the baby carefully, ensure attention to thermal care and inform the parents about progress.
- As soon as the baby appears stable, move to NICU as per normal practice
Transfer to NICU
- Two people are needed to effect the transfer from labour ward/theatre to NICU, one to move the mobile nHF and one to move the resuscitaire.
- On arrival in NICU, plug the mobile nHF into gas and power supplies (switch the manifold over)
- Ensure that there is a second, cotside Vapotherm (empty) unit
- Leave the baby in the resuscitaire and check the admission temperature.
- Stop the mobile nHF, remove the cartridge and place it into the cotside Vapotherm unit. Start it running, it should run straight away. Ensure that the correct temperature, flow and Fraction Of Inspired Oxygen (FiO2) are set
- This process takes less than 20 seconds and as the baby is breathing will not be detrimental
- Transfer the baby into the incubator and commence normal admission practices
- Document the resuscitation clearly in the baby's notes
Cleaning and charging the mobile nHF
- Remove the mobile nHF, clean the Vapotherm Precision flow nHF unit. Ensure the cylinders are switched off and plug into the wall to recharge the UPS.
- Conditions
- Premature Birth
- Being tested
- Vapotherm Precision Flow
- Keywords
- nasal High Flow, premature baby, CPAP (Continuous positive airways pressure)
- Medical subject headings
- Premature Birth, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapotherm Precision FlowDevice
Also called nasal High Flow device, nasal heated humidified high flow cannula
Application of nasal High Flow using 6-7 l/min delivered by nasal prongs from birth
| Study group | Role | What they receive |
|---|---|---|
| nasal High Flow applied | Experimental | Application of nasal High Flow 6-7l/min via nasal prongs after birth using a mobile Vapotherm Precision Flow device Receives: Device: Vapotherm Precision Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for endotracheal intubation prior to admission to Neonatal Unit
Babies who are clinically stable will not require intubation prior to admission to the neonatal unit.
Measured: From birth
Secondary outcomes (3)
Development of pneumothorax within 24 hours of birth
Pneumothorax is a rare but important outcome measure.
Measured: First 24 hours after birth
Requirement for endotracheal intubation and surfactant administration after admission to neonatal unit within 24 hours of birth
Intubation and surfactant administration after admission within the first 24 hours indicates severe respiratory distress syndrome requiring treatment according to agreed local protocols
Measured: First 24 hours after admission to neonatal unit
Development of bronchopulmonary dysplasia defined as oxygen requirement at 36 weeks corrected age
Bronchopulmonary dyplasia is an important outcome of the respiratory management of premature babies. We use the standard definition of an ongoing oxygen requirement at 36 weeks corrected age with compatible X-ray changes.
Measured: Defined at 36 weeks corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashford and St. Peter's Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Dr Reynolds, PhD, Principal investigator, Ashford and St. Peter's Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991886
- Sponsor's protocol ID
- 2013PR01
- Other IDs
- 131594
- Status last verified
- Aug 2016
- First submitted
- 11 Nov 2013
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Reynolds P, Leontiadi S, Lawson T, Otunla T, Ejiwumi O, Holland N. Stabilisation of premature infants in the delivery room with nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F284-7. doi: 10.1136/archdischild-2015-309442. Epub 2016 Jan 5.
PubMed 26733541
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Feasibility of the Use of Nasal High Flow From Birth in Premature Infants Born at Less Than or Equal to 30 Week Gestational Age.
- ClinicalTrials.gov ID
- NCT01991886
- Acronym / sponsor ID
- 2013PR01
- Conditions
- Premature Birth
- Keywords
- nasal High Flow, premature baby, CPAP (Continuous positive airways pressure)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ashford and St. Peter's Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Nov 2013 (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.
Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Those studies showed that even very small babies can be safely supported using nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to breath, albeit with additional support to reduce their work of breathing. However nCPAP has some drawbacks, including that it can cause skin damage to the nose, and that the heating and humidification of the gas is not always sufficient. We have been using, for over 5 years, a different system to support babies after routine intubation. This is another type of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior to nCPAP in respect it does not cause nose damage and its heating and humidification is excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation. This study is important to establish the feasibility of using nHF immediately after birth.
Detailed description
We propose to pilot the use of this mobile nHF unit, using the Vapotherm Precision Flow device, in the premature population of babies who would normally be either intubated and given surfactant routinely, or be maintained on nCPAP until arrival on the Neonatal Intensive Care Unit (NICU) then transferred onto nHF. Parents will be informed about the pilot and their permission will be sought. We aim to recruit 40 babies less than 30 weeks gestation.
The reason for undertaking a pilot study of this nature is to establish feasibility and proof of concept. It is not designed to be compared to using nCPAP to stabilise babies immediately after birth (although that will be the next and logical progression if this proves to be a feasible technique).
The hypothesis is that using nHF to stabilise babies immediately after birth will confer the same advantages as using nCPAP to stabilise babies in this way, which has been demonstrated in the worldwide literature. For units such as ours who use nHF in preference to nCPAP, this will be an important step in further defining the management of these babies after birth. There is evidence that nHF is at least as good as nCPAP in preventing intubation and reducing lung disease, and it may also offer additional advantages from humidification and reduction in nasal trauma.
The major challenge for this pilot project will be to identify eligible deliveries in a timely manner to ensure that a suitable member of staff is available to speak to parents and gain consent.
Once a delivery has been identified and the parents have agreed to take part, then the following process will take place to manage the newborn baby.
Check the mobile nHF unit
- The mobile nHF unit should be kept plugged in so that the uninterruptable power supply (UPS) is fully charged
- To use it, unplug it to check that the UPS is functioning (green lights indicate full charge), set up a Vapotherm circuit(as per normal routine) and start the machine running on UPS power supply.
- Gas supply should be from the cylinders to check that the pressures are 50bar in both air and oxygen cylinders
- Set the temperature to 37 degrees Celsius
- Once running, turn the unit off if not immediately needed or plug into the mains power and gas(es) where available to conserve gas. The unit can be run on a flow of 1 litre/minute whilst "ticking over" to conserve cylinder gas if needed.
- The prongs should be attached to the circuit.
Once the baby is born
- Place the baby in a polythene bag (as per normal practice)
- Ensure the baby is breathing. If not, or the baby is bradycardic, then normal resuscitation measures should be applied. It will only be appropriate to apply the mobile nHF if the baby is breathing and is clinically stable.
- Once the baby is born, increase the flow to 6 litres/min
- If the baby is breathing then apply the nHF prongs and observe carefully
- Suction should only be applied gently, if needed to remove excessive secretions in the mouth and throat. Babies on high flow will often "blow bubbles" and there may be lung fluid in the throat, but suction should not be vigorous
- Apply a saturation monitor (as per normal practice) to check Heart Rate (HR) and Oxygen Saturation (SaO2).
- Dry the baby's face sufficiently to be able to apply duoderm dressing to stick down the prongs to the cheeks.
- Observe the baby carefully, ensure attention to thermal care and inform the parents about progress.
- As soon as the baby appears stable, move to NICU as per normal practice
Transfer to NICU
- Two people are needed to effect the transfer from labour ward/theatre to NICU, one to move the mobile nHF and one to move the resuscitaire.
- On arrival in NICU, plug the mobile nHF into gas and power supplies (switch the manifold over)
- Ensure that there is a second, cotside Vapotherm (empty) unit
- Leave the baby in the resuscitaire and check the admission temperature.
- Stop the mobile nHF, remove the cartridge and place it into the cotside Vapotherm unit. Start it running, it should run straight away. Ensure that the correct temperature, flow and Fraction Of Inspired Oxygen (FiO2) are set
- This process takes less than 20 seconds and as the baby is breathing will not be detrimental
- Transfer the baby into the incubator and commence normal admission practices
- Document the resuscitation clearly in the baby's notes
Cleaning and charging the mobile nHF
- Remove the mobile nHF, clean the Vapotherm Precision flow nHF unit. Ensure the cylinders are switched off and plug into the wall to recharge the UPS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nasal High Flow applied | Experimental | Device: Vapotherm Precision FlowApplication of nasal High Flow 6-7l/min via nasal prongs after birth using a mobile Vapotherm Precision Flow device |
Who may qualify
- Ages
- 24 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parental consent
- 24+0 to 30+0 weeks(agreed dates) gestation born alive
- Breathing spontaneously at birth or soon after with minimal resuscitation
- Oxygen saturations >90% by 5 minutes
Key exclusion criteria (7 listed)
- No parental consent
- Born in poor condition and unlikely to survive
- Needing resuscitation including intubation and/or chest compressions
- Not breathing and thus needing intubation
- Oxygen saturations <90% by 5 minutes
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 |
|---|---|---|
| Vapotherm Precision FlowAlso: nasal High Flow device, nasal heated humidified high flow cannulaApplication of nasal High Flow using 6-7 l/min delivered by nasal prongs from birth | Device | nasal High Flow applied |
Primary outcome
Need for endotracheal intubation prior to admission to Neonatal Unit
Time frame: From birth
Babies who are clinically stable will not require intubation prior to admission to the neonatal unit.
3 secondary outcomes
Development of pneumothorax within 24 hours of birth
Time frame: First 24 hours after birth
Requirement for endotracheal intubation and surfactant administration after admission to neonatal unit within 24 hours of birth
Time frame: First 24 hours after admission to neonatal unit
Development of bronchopulmonary dysplasia defined as oxygen requirement at 36 weeks corrected age
Time frame: Defined at 36 weeks corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Derived from this study: PubMed 26733541Reynolds P, Leontiadi S, Lawson T, Otunla T, Ejiwumi O, Holland N. Stabilisation of premature infants in the delivery room with nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F284-7. doi: 10.1136/archdischild-2015-309442. Epub 2016 Jan 5.
- Individual participant dataSharing planned: Undecided
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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.
Peter Dr Reynolds, PhD principal investigator
Ashford and St. Peter's Hospitals NHS Foundation 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 Vapotherm Precision Flow in people with Premature Birth, run by Ashford and St. Peter's 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 12 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for endotracheal intubation prior to admission to Neonatal Unit (time frame: From birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991886, which also lists 1 linked publication.
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 12 Aug 2016.