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Trial registered on ANZCTR


Registration number
ACTRN12617000907347
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
20/06/2017
Date last updated
20/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reference values for the electrical activity of the diaphragm in neonates for use in neurally adjusted ventilation.
Scientific title
Neurally Adjusted Ventilatory Assist (NAVA) - Reference values for Electrical Activity of Diaphragm (Edi) in preterm and term neonates with no respiratory distress
Secondary ID [1] 292070 0
Nil known
Universal Trial Number (UTN)
U1111-1197-0419
Trial acronym
NAVA REdi Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal respiratory distress 303727 0
Condition category
Condition code
Respiratory 302914 302914 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 303100 303100 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neonates, with no existing respiratory conditions and no respiratory support, who have a nasogastric tube in-situ for feeding purposes will be enrolled in the study. When these neonates are due for a tube change, an appropriately sized Edi catheter will be inserted instead and used as a feeding tube. The catheter will be connected to a Servo-n ventilator and the Edi signal will be recorded for 4 hours which is the duration of the study. After 4 hours, the catheter will be disconnected from the ventilator and used as a standard feeding tube.
Intervention adherence will be assessed by participating researchers, research nurse and nurse educators through regular communication with data collector. The project will also be discussed during regular research meetings.
Intervention code [1] 298216 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302302 0
Edi peak (microvolts) - measured using a Servo-n ventilator
Timepoint [1] 302302 0
In 1 minute increments for the 4 hour duration of the study.
Primary outcome [2] 302303 0
Edi min (microvolts) - measured using a Servo-n ventilator
Timepoint [2] 302303 0
In 1 minute increments for the 4 hour duration of the study.
Secondary outcome [1] 335403 0
Respiratory rate (breaths/min) - measured using a Servo-n ventilator
Timepoint [1] 335403 0
In 1 minute increments for the 4 hour duration of the study.
Secondary outcome [2] 335404 0
Heart rate (beats/min) - measured using a standard pulse oximeter
Timepoint [2] 335404 0
Every 15 mins for the 4 hour duration of the study.
Secondary outcome [3] 335405 0
Oxygen saturation (%) - measured using a standard pulse oximeter
Timepoint [3] 335405 0
Every 15 mins for the 4 hour duration of the study.

Eligibility
Key inclusion criteria
Neonates of 29-42 gestation age, no respiratory support or existing respiratory conditions, nasogastric feeding tube in-situ, informed parental consent
Minimum age
0 Days
Maximum age
30 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known congenital anomalies, infants with respiratory distress, major neurologic conditions and brain anomalies, neuromuscular diseases, apneas, conditions affecting innervation of diaphragm

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample Size Calculation:
Using the estimated mean (+/-SD) Edi peak of 11+/-3 in term neonates, a sample size of 16 preterm and 16 term neonates, will be required to see the mean Edi difference of 30% for alpha 0.05 and power 0.80.

Planned Statistical Analysis:
Differences between groups will be determined by:
Chi-square or Fishers exact test for categorical data
t test for parametric continuous data
Wilcoxon rank-sum for non-parametric continuous data
Population means, standard deviations, and ranges will be calculated for the duration of the study.
Analysis of variance measures will be performed to compare the population means for each of the states.
Statistical significance is defined as P <0.05.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8209 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 16268 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 296602 0
Hospital
Name [1] 296602 0
Royal Hospital for Women
Address [1] 296602 0
Barker Street, Randwick NSW 2031
Country [1] 296602 0
Australia
Primary sponsor type
Individual
Name
Srinivas Bolisetty
Address
Department of Newborn Services, Royal Hospital for Women, Barker St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 295567 0
None
Name [1] 295567 0
Address [1] 295567 0
Country [1] 295567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297829 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 297829 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 297829 0
Australia
Date submitted for ethics approval [1] 297829 0
10/03/2017
Approval date [1] 297829 0
31/03/2017
Ethics approval number [1] 297829 0
HREC ref: 17/083

Summary
Brief summary
Neurally Adjusted Ventilatory Assist (NAVA) is a new ventilatory technique in neonates to aid babies with respiratory distress. It uses the baby's diaphragmatic electrical activity as a trigger for each breath. This electrical activity is measured using a special nasogastric tube (Edi catheter) with electrodes at the level of the diaphragm. To date, there is a little data on the Edi signal in neonates with no existing respiratory conditions and on no respiratory support. By gaining a reference Edi data range, clinicians will be better equipped to titrate NAVA levels in ventilated neonates. We hypothesise that Edi peak and Edi min were higher in (1) Higher gestational age group, (2) awake and postprandial states and (3) after caffeine administration (caffeine is only administered to those infants using the medication as part of their hospital treatment).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75214 0
Dr Srinivas Bolisetty
Address 75214 0
Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031
Country 75214 0
Australia
Phone 75214 0
+612 93826190
Fax 75214 0
+612 93826191
Email 75214 0
srinivas.bolisetty@health.nsw.gov.au
Contact person for public queries
Name 75215 0
Dr Srinivas Bolisetty
Address 75215 0
Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031
Country 75215 0
Australia
Phone 75215 0
+612 93826190
Fax 75215 0
+612 93826191
Email 75215 0
srinivas.bolisetty@health.nsw.gov.au
Contact person for scientific queries
Name 75216 0
Dr Srinivas Bolisetty
Address 75216 0
Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031
Country 75216 0
Australia
Phone 75216 0
+612 93826190
Fax 75216 0
+612 93826191
Email 75216 0
Srinivas.Bolisetty@health.nsw.gov.au

No data has been provided for results reporting
Summary results
Not applicable