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Trial registered on ANZCTR


Registration number
ACTRN12609000986279
Ethics application status
Approved
Date submitted
7/08/2009
Date registered
16/11/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized controlled trial of modes of ventilatory support in preterm babies from point of delivery to the neonatal intensive care unit.
Scientific title
In preterm babies born at the Nepean Hospital less than 30 weeks’ gestational age and requiring ventilation in the delivery suite, would the use of volume-targeted ventilation as compared to standard intermittent mandatory ventilation from the point of delivery until admission to the neonatal intensive care unit reduce the incidence of hypocarbia in the first 2 days of life?
Secondary ID [1] 947 0
Nil
Universal Trial Number (UTN)
Trial acronym
TARDIS (Targeted Delivery Suite Intervention Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood carbon dioxide on admission to the Neonatal Intensive Care Unit (NICU) 243476 0
Blood oxygen level on admission to the NICU 243477 0
Oxygen saturation and blood delivery to the brain, as measured by Near Infra-Red Spectroscopy (NIRS) 243478 0
Development of intra-ventricular haemorrhage and/or periventricular leukomalacia 243479 0
Presence or absence of cerebral autoregulation as determined by NIRS and its relationship to hypocarbia on arrival in the NICU 243480 0
Condition category
Condition code
Respiratory 239777 239777 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 239778 239778 0 0
Complications of newborn
Neurological 239779 239779 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Triggered, volume-targeted mechanical ventilation (for those newborns that require ventilation) from the delivery suite to the neonatal intensive care unit.  Ventilator set to target an exhaled tidal volume of 5 mL/kg with inspiratory pressures automatically adjusted breath-to-breath by the ventilator depending on pulmonary compliance. Cerebral oxygenation monitoring using spatially resolved near infra-red spectroscopy in the first 48 hours of life; ultrasound assessment of cardiac output and presence of a patent ductus arteriosus in the first 48 hours of life.
Intervention code [1] 237096 0
Prevention
Intervention code [2] 237097 0
Treatment: Devices
Comparator / control treatment
Standard non triggered intermittent mandatory ventilation (for those newborns that require ventilation) from the delivery suite to the neonatal intensive care unit. Ventilator set at regular 60 breaths per minute, positive end-expiratory pressure of 5cm, positive inspiratory pressure set by the medical team and based on the newborn's chest movements. Nasal continuous positive airways pressure support for those newborns not requiring active ventilation. Cerebral oxygenation monitoring using spatially resolved near infra-red spectroscopy in the first 48 hours of life; ultrasound assessment of cardiac output and presence of a patent ductus arteriosus in the first 48 hours of life.
Control group
Active

Outcomes
Primary outcome [1] 240544 0
hypocarbia; partial pressure of carbon dioxide in arterial blood (PaCO2) < 30mmHg
Timepoint [1] 240544 0
on arrival in the neonatal intensive care unit
Primary outcome [2] 240545 0
hyperoxia; partial pressure of oxygen in arterial blood (PaO2) > 100mmHg
Timepoint [2] 240545 0
on arrival in the neonatal intensive care unit
Secondary outcome [1] 257120 0
reduced cerebral blood flow as measured by near infra-red spectroscopy
Timepoint [1] 257120 0
measurement periods of 2 hours' duration; measurements performed as soon as possible after admission to the neonatal intensive care unit, then at the age of 12, 24 and 36 hours of life.
Secondary outcome [2] 257121 0
development of severe (grade 3 or 4) intraventricular haemorrhage as assessed by cranial ultrasound scan
Timepoint [2] 257121 0
cranial ultrasound scan measurements performed as soon as possible after admission to the neonatal intensive care unit, then at 12, 24 and 36 hours' age, then at chronological age of 1 week and 2 weeks.
Secondary outcome [3] 257122 0
development of periventricular leukomalacia as assessed by cranial ultrasound scan
Timepoint [3] 257122 0
cranial ultrasound scan measurements performed at chronological age of 6 weeks, then again at term corrected age or prior to discharge home.
Secondary outcome [4] 257123 0
death
Timepoint [4] 257123 0
within 28 days of birth
Secondary outcome [5] 257124 0
development of chronic lung disease (requiring oxygen at 36 weeks' corrected gestational age in order to maintain oxygen saturations, as measured by a peripheral transcutaneous oxygen saturation monitor, above 92%)
Timepoint [5] 257124 0
based on continuous monitoring at 36 weeks' corrected gestational age
Secondary outcome [6] 257125 0
neurodevelopmental disability (graded as mild, moderate or severe) as assessed by a formal Bayley 3 assessment.
Timepoint [6] 257125 0
at age 1 and 3 years

Eligibility
Key inclusion criteria
Preterm babies less than 30 weeks’ gestation at birth
Minimum age
23 Weeks
Maximum age
29 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspected pulmonary hypoplasia, suspected chromosomal abnormality or a suspected syndrome.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed, numbered opaque envelopes, opened only if the baby requires some form of respiratory support (either intubation or nasal CPAP) the baby is NOT ineligible if he or she does not require respiratory support at the point of delivery.Ventilation in the neonatal intensive care unit (NICU) uses a variety of different modes, all considered to be safe, including volume “targeted” ventilation known as “volume guarantee” or VG on the commonly available Draeger neonatal ventilator. Local (within each hospital) neonatal transport systems, specifically from the delivery suite to the NICU, are not standard and most hospitals will have a standard ventilator capable only of intermittent mandatory ventilation (IMV).All preterm babies less than 32 weeks are assessed at birth regarding their need for respiratory support. Most will need intubation and mechanical ventilation, the standard of care for this is currently to use IMV from the delivery suite to the NICU; a small group of these babies may not require ventilation but will need continuous positive airway pressure (CPAP) support. If the newborn baby requires ventilation, as assessed by the medical practitioner on clinical service and independent of the researcher, it will be weighed, intubated as per current practice. During the intubation process, the researcher will open the relevant envelope and thus randomise the newborn to receive either the standard IMV or the triggered VG mode of ventilation, the latter being the interventional mode only as regards transport from the delivery suite to the NICU (as explained above). If the newborn is deemed not to require ventilation, it will receive CPAP but will still be included as a control group within this study.An attempt to obtain consent to enrol each baby will be made prior to the delivery/birth of the newborn. In cases of rapid labour/delivery where consent cannot be obtained before the delivery/birth of the baby, the baby will be initially enrolled and consent will be sought within the next 6 hours, depending on the clinical condition of the mother if the father is not available. Parents will have the right to request withdrawal from the study at any point.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a sequence generated by computer software: Graphpad Statmate. Stratification for 2 groups of gestational ages: (a) 23 weeks (+ 0 days) to 26 weeks (+ 6 days), (b) 27 weeks (+ 0 days) to 29 weeks (+ 6 days)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237468 0
Self funded/Unfunded
Name [1] 237468 0
Country [1] 237468 0
Primary sponsor type
Individual
Name
Dr Mark Tracy
Address
NICU, Nepean Hospital
Derby Street
Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 236955 0
Hospital
Name [1] 236955 0
Nepean Hospital
Address [1] 236955 0
Nepean Hospital
Derby Street
Kingswood, NSW 2747
Country [1] 236955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239595 0
Nepean Hospital Ethics Committee
Ethics committee address [1] 239595 0
Ethics committee country [1] 239595 0
Australia
Date submitted for ethics approval [1] 239595 0
Approval date [1] 239595 0
17/10/2006
Ethics approval number [1] 239595 0
HREC No: 06/063 TARDIS Study

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30021 0
Address 30021 0
Country 30021 0
Phone 30021 0
Fax 30021 0
Email 30021 0
Contact person for public queries
Name 13268 0
Dr Mark Tracy
Address 13268 0
NICU, Nepean Hospital
P.O. Box 63
Penrith NSW 2751
Country 13268 0
Australia
Phone 13268 0
+61 414324162
Fax 13268 0
+61 2 47342698
Email 13268 0
[email protected]
Contact person for scientific queries
Name 4196 0
Dr Mark Tracy
Address 4196 0
NICU, Nepean Hospital
P.O. Box 63
Penrith NSW 2751
Country 4196 0
Australia
Phone 4196 0
+61 414324162
Fax 4196 0
+61 2 47342698
Email 4196 0
[email protected]

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

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