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| ID | Type | Description | Link |
|---|---|---|---|
| 131594 | Other Identifier | IRAS |
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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.
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
Once the baby is born
Transfer to NICU
Cleaning and charging the mobile nHF
o 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vapotherm Precision Flow | Device | Application of nasal High Flow using 6-7 l/min delivered by nasal prongs from birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From birth |
| Measure | Description | Time Frame |
|---|---|---|
| Development of pneumothorax within 24 hours of birth | Pneumothorax is a rare but important outcome measure. | First 24 hours after birth |
| Requirement for endotracheal intubation and surfactant administration after admission to neonatal unit within 24 hours of birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Dr Reynolds, PhD | Ashford and St. Peter's Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal ICU, St Peter's Hospital | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26733541 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| C564247 | Microcephaly, Primary Autosomal Recessive, 6 |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Intubation and surfactant administration after admission within the first 24 hours indicates severe respiratory distress syndrome requiring treatment according to agreed local protocols |
| 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. | Defined at 36 weeks corrected age |
| D000091642 | Urogenital Diseases |