The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000156088
Ethics application status
Approved
Date submitted
11/02/2010
Date registered
16/02/2010
Date last updated
12/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Neurological risk factors in infants having non-cardiac surgery, and their relationship to growth and neurodevelopmental outcome
Scientific title
A non-randomised study assessing the neurological risk factors in infants having non-cardiac surgery, and their relationship to growth and neurodevelopmental outcome.
Secondary ID [1] 1411 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital diaphragmatic hernia 256800 0
Oesophageal Atresia 256801 0
Anterior abdominal wall defect (Gastroschisis or exomphalos) 291151 0
Condition category
Condition code
Neurological 256953 256953 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment will be with a combination of neurobehavioural assessment, amplitude integated electroencephalography (aEEG) and magnetic resonance imaging (MRI). Neurobehavioural assessment will be conducted by the Bayley III at 1 year and 2 years corrected gestational age. This assessment takes approximately two hours. MRI will be acquired at two time points- pre-operatively and post-operatively. Participants will have aEEG placed in the post-operative period. The type of surgery that the participants in this study will undergo are congenital diaphragmatic hernia repair, oesophageal atresia repair or anterior abdominal wall defect repair.
Intervention code [1] 256008 0
Not applicable
Comparator / control treatment
Abnormalities of cerebral development associated with preterm birth will be identified by comparison of MRI and aEEG data from healthy, late-born infants, as well as comparison with a cohort of late preterm infants with gestational ages 32-36 weeks who are being studied elsewhere. Specifically these 'healthy' late preterm infants are currently being recruited into a study of cerebral development using MRI being performed at the Royal Women's Hospital by a co-investigator Dr Jeanie Cheong. This study commenced in 2010.

Control group
Historical

Outcomes
Primary outcome [1] 257826 0
Neurodevelopmental outcome measured by the Bayley-III
Timepoint [1] 257826 0
Participants will be tested at 24 months of age.
Secondary outcome [1] 263246 0
Evidence of cerebral structural derangement from advanced magnetic resonance (MR) analysis
Timepoint [1] 263246 0
Preoperatively and post-operatively (4 weeks after surgery)
Secondary outcome [2] 263247 0
Evidence of peri-operative disturbance in cerebral function measured by analysis of background pattern on aEEG, or presence of seizures.
Timepoint [2] 263247 0
Immediately after surgery until sleep wake cycling resumes.

Eligibility
Key inclusion criteria
All infants born after 31 completed weeks gestation with either congenital diaphragmatic hernia, oesophageal atresia or anterior abdominal wall defect.
Minimum age
1 Days
Maximum age
1 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment hospital [1] 2079 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 7771 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 256510 0
University
Name [1] 256510 0
Melbourne University
Address [1] 256510 0
The University of Melbourne
Victoria 3010
Country [1] 256510 0
Australia
Funding source category [2] 288712 0
Charities/Societies/Foundations
Name [2] 288712 0
Centres of Clinical Research Excellence (CCRE) in Newborn Medicine
Murdoch Childrens Research Institute
Address [2] 288712 0
Flemington Road
Parkville Vic 3052
Country [2] 288712 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Road,
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 255820 0
None
Name [1] 255820 0
Address [1] 255820 0
Country [1] 255820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258558 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 258558 0
Flemington Road
Parkville
Victoria, 3052
Ethics committee country [1] 258558 0
Australia
Date submitted for ethics approval [1] 258558 0
15/02/2010
Approval date [1] 258558 0
29/04/2010
Ethics approval number [1] 258558 0

Summary
Brief summary
The primary purpose of this study is the examine the cerebral injury and changes in cerebral structure in late preterm and term infants undergoing surgery using neurobehvavioural, electrophysiology and MR imaging.
Our study hypothesis is that childhood survivors of infants undergoing surgery in the newborn period for conditions including oesophageal atresia, congenital diaphragmatic hernia and gastroschisis will have impaired neurodevelopment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30831 0
A/Prof Rod Hunt
Address 30831 0
Neonatal Research
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 30831 0
Australia
Phone 30831 0
+613934 55008
Fax 30831 0
Email 30831 0
Rod.Hunt@rch.org.au
Contact person for public queries
Name 14078 0
A/Prof Rod Hunt
Address 14078 0
Department of Neonatal Medicine
Royal Children's Hospital
Flemington Road
Parkville
Victoria, 3052
Country 14078 0
Australia
Phone 14078 0
+61 3 9345 5008
Fax 14078 0
Email 14078 0
rod.hunt@rch.org.au
Contact person for scientific queries
Name 5006 0
A/Prof Rod Hunt
Address 5006 0
Department of Neonatal Medicine
Royal Children's Hospital
Flemington Road
Parkville
Victoria, 3052
Country 5006 0
Australia
Phone 5006 0
+61 3 9345 5008
Fax 5006 0
Email 5006 0
rod.hunt@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary