Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421519
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-09
Brief Title:
Different Levels of BiPAP
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
Crossover Study of the Work of Breathing at Different Levels of BiPAP Settings in Neonates
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some infants with breathing problems at birth may need to be connected to a machine to help support their breathing The purpose of this study is to optimise the level of breathing support on Bi level continuous airway pressure BiPAP a support which gives two levels of support pressure to premature infants
The study is investigating which upper pressure gives the best support that is results in the baby having to breathe less hard work of breathing
Researchers will measure the work of breathing using a small catheter Infants will receive three different upper pressures of BiPAP with the same baseline pressure for 20 minutes each In between each upper level they will receive the standard upper pressure for 20 minutes
The study is investigating which upper pressure gives the best support that is results in the baby having to breathe less hard work of breathing
Researchers will measure the work of breathing using a small catheter Infants will receive three different upper pressures of BiPAP with the same baseline pressure for 20 minutes each In between each upper level they will receive the standard upper pressure for 20 minutes
Detailed Description:
Bilevel continuous positive airway pressure BiPAP is a type of non-invasive respiratory support which can be used as breathing support in neonates requiring some pressure support to help their breathing BiPAP provides cycles of higher and lower pressure levels at set intervals usually with a baseline pressure constant of 5cm H2O
In the UK other forms of non-invasive ventilation such as NIPPV and NIV-NAVA have been shown to be efficacious however they are expensive BiPAP may therefore provide a viable and cost-effective alternative Currently there are no written guidelines about BiPAP use
The investigators aim to identify the most efficacious BiPAP settings for preterm infants as primary support and post-extubation as well as in those with evolving BPD Infants will be studied at three different upper pressure settings for a period of 20 minutes each The work of breathing will be measured from small pressure transducers situated on a thin catheter the size of a feeding tube The catheter will be passed through the mouth and positioned so the tip is in the stomach Simultaneous measurements for work of breathing using transcutaneous diaphragm electromyography will also be taken Following the study the infant will subsequently be nursed on the breathing support type associated with the lower work of breathing
The investigators aim to recruit 21 patients with 7 in each arm of the trial Sample size was derived using previous study results in which the SD of the PTPdi was 78cmH2Osmin in 40 preterm infants of 28-34 weeks gestation and a clinically significant difference of 133cmH2Osmin was observed between infants on SNIPPV against high flow NIV support To detect such a difference with 90 power and 5 significance 7 infants would be required in each group that is 21 infants in total in 3 groups
The parents of potential participants will be approached by the clinical team initially subsequently the research fellow will provide them with the study information Responsibility for recording and dating oral electronic and written informed consent or advice will be with the researchers identified in the formal delegation log
Full analyses will be detailed in a statistical analysis plan SAP which will be finalised prior to the end of data collection Any exploratory analyses of sub-groups that are of clinical interest will be pre-specified in the SAP Any deviations from the original SAP will be described and justified in protocol andor in final report as appropriate This trial will be reported according to the CONSORT guidelines for clinical trials Consolidated Standards Of Reporting Trials statement Statistical significance will be at 5 level and analyses will be conducted in STATA A summary of the planned statistical analysis is included here
Descriptive statistics will be used to describe infant demographics Standard statistical summaries eg medians and ranges or means and variances or proportions and percentages dependent on the distribution of the outcomes
The main analysis will investigate work of breathing at baseline and at each of the 3 upper BiPAP pressure settings Data will be assessed for normality If data is not normally distributed non-parametric statistics will be used 95 confidence intervals will be reported throughout Missing data will be described with reasons given where available
Data collected during the study will be handled and stored in accordance with the General Data Protection Regulation and Data Protection Act 2018 which requires data to be de-identified as soon as it is practical to do so All data will be completely anonymised for purposes of analysis and any subsequent reports or publications For the purposes of ongoing data management once randomised individual patients will only be identified by trial numbers
Data will be downloaded from ventilators and pressure transducers to excel using secure password encrypted USB device Data will be uploaded on password protected servers only and anonymised at the point of entry
Data will be anonymised and identified by a unique identification number Trial number only A trial enrolment log at the sites will list the ID numbers
Paper study documents will be held at the trial site in a secure location for the duration of the trial All essential documents will be retained until children reach 25 years old as per protocol
A statement of permission to access source data by study staff and for regulatory and audit purposes will be included within the primary care givers consent form with explicit explanation as part of the consent process and Participant Information Sheet
In principle anonymised data will be made available for meta-analysis and if requested by other authorised researchers and journals for publication purposes Requests for access to data will be reviewed by the Chief Investigator
Each adverse event will be assessed for severity causality seriousness and expectedness All adverse events will be recorded in the medical records in the first instance All adverse events will be recorded with clinical symptoms and accompanied with a simple brief description of the event including dates as appropriate All serious adverse events will be recorded in the medical records and the CRF
The Chief Investigator will ensure there are adequate quality and number of monitoring activities conducted by the study team This will include adherence to the protocol procedures for consenting and ensure adequate data quality
In the UK other forms of non-invasive ventilation such as NIPPV and NIV-NAVA have been shown to be efficacious however they are expensive BiPAP may therefore provide a viable and cost-effective alternative Currently there are no written guidelines about BiPAP use
The investigators aim to identify the most efficacious BiPAP settings for preterm infants as primary support and post-extubation as well as in those with evolving BPD Infants will be studied at three different upper pressure settings for a period of 20 minutes each The work of breathing will be measured from small pressure transducers situated on a thin catheter the size of a feeding tube The catheter will be passed through the mouth and positioned so the tip is in the stomach Simultaneous measurements for work of breathing using transcutaneous diaphragm electromyography will also be taken Following the study the infant will subsequently be nursed on the breathing support type associated with the lower work of breathing
The investigators aim to recruit 21 patients with 7 in each arm of the trial Sample size was derived using previous study results in which the SD of the PTPdi was 78cmH2Osmin in 40 preterm infants of 28-34 weeks gestation and a clinically significant difference of 133cmH2Osmin was observed between infants on SNIPPV against high flow NIV support To detect such a difference with 90 power and 5 significance 7 infants would be required in each group that is 21 infants in total in 3 groups
The parents of potential participants will be approached by the clinical team initially subsequently the research fellow will provide them with the study information Responsibility for recording and dating oral electronic and written informed consent or advice will be with the researchers identified in the formal delegation log
Full analyses will be detailed in a statistical analysis plan SAP which will be finalised prior to the end of data collection Any exploratory analyses of sub-groups that are of clinical interest will be pre-specified in the SAP Any deviations from the original SAP will be described and justified in protocol andor in final report as appropriate This trial will be reported according to the CONSORT guidelines for clinical trials Consolidated Standards Of Reporting Trials statement Statistical significance will be at 5 level and analyses will be conducted in STATA A summary of the planned statistical analysis is included here
Descriptive statistics will be used to describe infant demographics Standard statistical summaries eg medians and ranges or means and variances or proportions and percentages dependent on the distribution of the outcomes
The main analysis will investigate work of breathing at baseline and at each of the 3 upper BiPAP pressure settings Data will be assessed for normality If data is not normally distributed non-parametric statistics will be used 95 confidence intervals will be reported throughout Missing data will be described with reasons given where available
Data collected during the study will be handled and stored in accordance with the General Data Protection Regulation and Data Protection Act 2018 which requires data to be de-identified as soon as it is practical to do so All data will be completely anonymised for purposes of analysis and any subsequent reports or publications For the purposes of ongoing data management once randomised individual patients will only be identified by trial numbers
Data will be downloaded from ventilators and pressure transducers to excel using secure password encrypted USB device Data will be uploaded on password protected servers only and anonymised at the point of entry
Data will be anonymised and identified by a unique identification number Trial number only A trial enrolment log at the sites will list the ID numbers
Paper study documents will be held at the trial site in a secure location for the duration of the trial All essential documents will be retained until children reach 25 years old as per protocol
A statement of permission to access source data by study staff and for regulatory and audit purposes will be included within the primary care givers consent form with explicit explanation as part of the consent process and Participant Information Sheet
In principle anonymised data will be made available for meta-analysis and if requested by other authorised researchers and journals for publication purposes Requests for access to data will be reviewed by the Chief Investigator
Each adverse event will be assessed for severity causality seriousness and expectedness All adverse events will be recorded in the medical records in the first instance All adverse events will be recorded with clinical symptoms and accompanied with a simple brief description of the event including dates as appropriate All serious adverse events will be recorded in the medical records and the CRF
The Chief Investigator will ensure there are adequate quality and number of monitoring activities conducted by the study team This will include adherence to the protocol procedures for consenting and ensure adequate data quality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None