ANZCTR - Registration

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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]

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

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

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]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Edi peak (microvolts) - measured using a Servo-n ventilator

Timepoint [1]

In 1 minute increments for the 4 hour duration of the study.

Primary outcome [2]

Edi min (microvolts) - measured using a Servo-n ventilator

Timepoint [2]

In 1 minute increments for the 4 hour duration of the study.

Secondary outcome [1]

Respiratory rate (breaths/min) - measured using a Servo-n ventilator

Timepoint [1]

In 1 minute increments for the 4 hour duration of the study.

Secondary outcome [2]

Heart rate (beats/min) - measured using a standard pulse oximeter

Timepoint [2]

Every 15 mins for the 4 hour duration of the study.

Secondary outcome [3]

Oxygen saturation (%) - measured using a standard pulse oximeter

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

13/04/2017

Date of last participant enrolment

Anticipated

24/08/2017

Actual

Date of last data collection

Anticipated

31/08/2017

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Hospital for Women - Randwick

Recruitment postcode(s) [1]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Hospital for Women

Address [1]

Barker Street, Randwick NSW 2031

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Room G71 East Wing 
Edmund Blacket Building 
Prince of Wales Hospital
Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/03/2017

Approval date [1]

31/03/2017

Ethics approval number [1]

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

Attachments [1]

/AnzctrAttachments/373039-NAVA REdi Project synposis v4_20170328_without tracked changes.docx (Protocol)

Attachments [2]

/AnzctrAttachments/373039-NAVA-REDI Parent Information and Consent Form V5_20170328_without tracked changes.docx (Participant information/consent)

Contacts

Principal investigator

Name

Dr Srinivas Bolisetty

Address

Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031

Country

Australia

Phone

+612 93826190

Fax

+612 93826191

srinivas.bolisetty@health.nsw.gov.au

Contact person for public queries

Name

Srinivas Bolisetty

Address

Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031

Country

Australia

Phone

+612 93826190

Fax

+612 93826191

srinivas.bolisetty@health.nsw.gov.au

Contact person for scientific queries

Name

Srinivas Bolisetty

Address

Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031

Country

Australia

Phone

+612 93826190

Fax

+612 93826191

Srinivas.Bolisetty@health.nsw.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Lying Around: Australasian Positioning Survey	2018	https://doi.org/10.1111/jpc.13882_330
Dimensions AI	Lying Around: Staff Positioning Survey in Two Neonatal Intensive Care Units (NICUS)	2018	https://doi.org/10.1111/jpc.13882_329
Dimensions AI	Neurally Adjusted Ventilatory Assist (NAVA): Reference Values for the Electrical Activity of the Diaphragm (Edi) in Neonates	2018	https://doi.org/10.1111/jpc.13882_331
Dimensions AI	The Rare Case of a Perforated Peptic Ulcer Post-Caesarean Section: Important Lessons and a Review of the Literature	2018	https://doi.org/10.1111/jpc.13882_332

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically