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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00756600




Registration number
NCT00756600
Ethics application status
Date submitted
18/09/2008
Date registered
22/09/2008
Date last updated
29/04/2020

Titles & IDs
Public title
A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
Scientific title
A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants
Secondary ID [1] 0 0
06-07-0320
Universal Trial Number (UTN)
Trial acronym
GAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Regional Anesthesia
Treatment: Drugs - General Anesthesia

Active comparator: 1 - Regional Anesthesia

Active comparator: 2 - General Anesthesia


Treatment: Drugs: Regional Anesthesia
Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.

Treatment: Drugs: General Anesthesia
Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Full Scale IQ Score
Timepoint [1] 0 0
At 5 years chronological age
Secondary outcome [1] 0 0
Verbal IQ
Timepoint [1] 0 0
At 5 years corrected age.
Secondary outcome [2] 0 0
Performance IQ
Timepoint [2] 0 0
At 5 years corrected age
Secondary outcome [3] 0 0
Processing Speed Quotient
Timepoint [3] 0 0
At 5 years corrected age
Secondary outcome [4] 0 0
Sentence Repetition Scaled Score
Timepoint [4] 0 0
At 5 years chronological age
Secondary outcome [5] 0 0
Auditory Attention Combined Scaled Score
Timepoint [5] 0 0
At 5 years corrected age
Secondary outcome [6] 0 0
Statue Scaled Score
Timepoint [6] 0 0
At 5 years corrected age
Secondary outcome [7] 0 0
Inhibition Combined Scaled Score
Timepoint [7] 0 0
At 5 years corrected age
Secondary outcome [8] 0 0
Word Generation Scaled Score
Timepoint [8] 0 0
At 5 years corrected age
Secondary outcome [9] 0 0
Affect Recognition Scaled Score
Timepoint [9] 0 0
At 5 years corrected age
Secondary outcome [10] 0 0
Memory for Names and Memory for Names Delay
Timepoint [10] 0 0
At 5 years corrected age
Secondary outcome [11] 0 0
Theory of Mind Scaled Score
Timepoint [11] 0 0
At 5 years corrected age
Secondary outcome [12] 0 0
Speeded Naming Combined Scaled Score
Timepoint [12] 0 0
At 5 years corrected age
Secondary outcome [13] 0 0
Fingertip Tapping Repetitions Scaled Score
Timepoint [13] 0 0
At 5 years corrected age
Secondary outcome [14] 0 0
Fingertip Tapping Sequences Scaled Score
Timepoint [14] 0 0
At 5 years corrected age
Secondary outcome [15] 0 0
Design Copy Process Total Scaled Score
Timepoint [15] 0 0
At 5 years corrected age
Secondary outcome [16] 0 0
Word Reading Standard Score
Timepoint [16] 0 0
At 5 years chronological age
Secondary outcome [17] 0 0
Numerical Operations Standard Score
Timepoint [17] 0 0
At 5 years chronological age
Secondary outcome [18] 0 0
Spelling Standard Score
Timepoint [18] 0 0
At 5 years chronological age
Secondary outcome [19] 0 0
Numbers Total Scaled Score
Timepoint [19] 0 0
At 5 years chronological age
Secondary outcome [20] 0 0
Word Lists 1 (Learning) Scaled Score
Timepoint [20] 0 0
At 5 years chronological age
Secondary outcome [21] 0 0
Memory and Learning Word Lists II (Delayed) Scaled Score
Timepoint [21] 0 0
At 5 years chronological age
Secondary outcome [22] 0 0
The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function
Timepoint [22] 0 0
At 5 years chronological age
Secondary outcome [23] 0 0
The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System
Timepoint [23] 0 0
At 5 years chronological age
Secondary outcome [24] 0 0
Total Problems Score
Timepoint [24] 0 0
At 5 years chronological age
Secondary outcome [25] 0 0
Internalising Problems T Score
Timepoint [25] 0 0
At 5 years chronological age
Secondary outcome [26] 0 0
Externalising Problems T Score
Timepoint [26] 0 0
At 5 years chronological age
Secondary outcome [27] 0 0
Speech or Language Interventions
Timepoint [27] 0 0
At 5 years chronological age
Secondary outcome [28] 0 0
Psychomotor Interventions
Timepoint [28] 0 0
At 5 years chronological age
Secondary outcome [29] 0 0
Number of Participants With Global Developmental Delay
Timepoint [29] 0 0
At 5 years chronological age
Secondary outcome [30] 0 0
Number of Participants With Attention Deficit Hyperactivity Disorder
Timepoint [30] 0 0
At 5 years chronological age
Secondary outcome [31] 0 0
Number of Participants With Autism Spectrum Disorder
Timepoint [31] 0 0
At 5 years chronological age
Secondary outcome [32] 0 0
Number of Participants With a Hearing Abnormality
Timepoint [32] 0 0
At 5 years chronological age
Secondary outcome [33] 0 0
Number of Participants With a Visual Defect in Either Eye
Timepoint [33] 0 0
At 5 years chronological age
Secondary outcome [34] 0 0
Number of Participants With a Hearing Aid
Timepoint [34] 0 0
At 5 years chronological age
Secondary outcome [35] 0 0
Number of Participants Who Are Legally Blind
Timepoint [35] 0 0
At 5 years chronological age
Secondary outcome [36] 0 0
Number of Participants Who Have Cerebral Palsy
Timepoint [36] 0 0
At 5 years chronological age
Secondary outcome [37] 0 0
Parents' Awareness of Group Allocation
Timepoint [37] 0 0
At 5 years chronological age
Secondary outcome [38] 0 0
Awareness of Group Allocation by Psychologist
Timepoint [38] 0 0
At 5 years chronological age
Secondary outcome [39] 0 0
Awareness of Group Allocation by Pediatrician
Timepoint [39] 0 0
At 5 years chronological age

Eligibility
Key inclusion criteria
* Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision)
* Any infant whose gestational age is 26 weeks or more (GA = 182 days)
* Any infant whose post-menstrual age is up to 60 weeks (PMA = 426 days)
Minimum age
No limit
Maximum age
60 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any child older than 60 weeks post-menstrual age
* Any child born less than 26 weeks gestation
* Any contraindication to general or spinal/caudal anesthesia (for example: neuromuscular disorder or coagulopathy)
* Pre-operative ventilation immediately prior to surgery
* Congenital heart disease that has required ongoing pharmacotherapy
* Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development
* Children where follow-up would be difficult for geographic or social reasons
* Families where English is not the primary language spoken at home
* Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra ventricular hemorrhage (ICH) (+/- post hemorrhage ventricular dilation)
* Previous exposure to volatile anesthesia or benzodiazepines as a neonate or in the third trimester in utero.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2018
Sample size
Target
Accrual to date
Final
643
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Adelaide Women's and Children's Hospital - North Adelaide
Recruitment hospital [2] 0 0
Casey Hospital - Berwick
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital - Perth
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
3806 - Berwick
Recruitment postcode(s) [3] 0 0
3165 - Clayton
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Vermont
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Italy
State/province [12] 0 0
Bergamo
Country [13] 0 0
Italy
State/province [13] 0 0
Genoa
Country [14] 0 0
Italy
State/province [14] 0 0
Milano
Country [15] 0 0
Netherlands
State/province [15] 0 0
Groningen
Country [16] 0 0
Netherlands
State/province [16] 0 0
Utrecht
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Belfast
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Birmingham
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Bristol
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Glasgow
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Liverpool
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
Boston Children's Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Children's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Hospital for Sick Children
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Murdoch Childrens Research Institute
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Food and Drug Administration (FDA)
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Andrew Davidson, MD
Address 0 0
Royal Children's Hospital, Victoria, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00756600