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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants
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Secondary ID [1]
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0
06-07-0320
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Universal Trial Number (UTN)
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Trial acronym
GAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernia
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Full Scale IQ Score
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Assessment method [1]
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The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability.
Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome).
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [1]
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At 5 years chronological age
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Secondary outcome [1]
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Verbal IQ
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Assessment method [1]
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Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Verbal IQ
Minimum possible score:45 Maximum possible score:145
A higher score indicates higher verbal IQ (better outcome).
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [1]
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0
At 5 years corrected age.
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Secondary outcome [2]
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Performance IQ
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Assessment method [2]
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Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Performance IQ
Minimum possible score:45 Maximum possible score:145
A higher score indicates a higher performance IQ (better outcome).
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [2]
0
0
At 5 years corrected age
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Secondary outcome [3]
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Processing Speed Quotient
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Assessment method [3]
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Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Processing speed quotient
Minimum possible score:45 Maximum possible score:145
A higher score indicates a better outcome.
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [3]
0
0
At 5 years corrected age
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Secondary outcome [4]
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0
Sentence Repetition Scaled Score
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Assessment method [4]
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Developmental Neuropsychological Assessment second edition (NEPSY-II) sub test: Sentence Repetition scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [4]
0
0
At 5 years chronological age
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Secondary outcome [5]
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0
Auditory Attention Combined Scaled Score
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Assessment method [5]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Auditory Attention combined scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [5]
0
0
At 5 years corrected age
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Secondary outcome [6]
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0
Statue Scaled Score
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Assessment method [6]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Statue scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [6]
0
0
At 5 years corrected age
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Secondary outcome [7]
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0
Inhibition Combined Scaled Score
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Assessment method [7]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Inhibition combined scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [7]
0
0
At 5 years corrected age
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Secondary outcome [8]
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0
Word Generation Scaled Score
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Assessment method [8]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Word Generation Scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [8]
0
0
At 5 years corrected age
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Secondary outcome [9]
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0
Affect Recognition Scaled Score
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Assessment method [9]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Affect Recognition scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [9]
0
0
At 5 years corrected age
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Secondary outcome [10]
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Memory for Names and Memory for Names Delay
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Assessment method [10]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Memory for Names and Memory for Names Delay
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [10]
0
0
At 5 years corrected age
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Secondary outcome [11]
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Theory of Mind Scaled Score
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Assessment method [11]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Theory of Mind scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [11]
0
0
At 5 years corrected age
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Secondary outcome [12]
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Speeded Naming Combined Scaled Score
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Assessment method [12]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Speeded Naming combined scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [12]
0
0
At 5 years corrected age
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Secondary outcome [13]
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0
Fingertip Tapping Repetitions Scaled Score
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Assessment method [13]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test:Fingertip tapping repetitions scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score is indicative of a better outcome.
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Timepoint [13]
0
0
At 5 years corrected age
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Secondary outcome [14]
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Fingertip Tapping Sequences Scaled Score
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Assessment method [14]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: fingertip tapping sequences scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [14]
0
0
At 5 years corrected age
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Secondary outcome [15]
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Design Copy Process Total Scaled Score
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Assessment method [15]
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Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Design Copy Process Total Scaled Score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [15]
0
0
At 5 years corrected age
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Secondary outcome [16]
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0
Word Reading Standard Score
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Assessment method [16]
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Weschler Individual Achievement Test (WIAT-II Abbreviated) to assess the academic skills of the child: Word Reading standard score
Minimum possible score: 45 Maximum possible score: 145
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
A higher score indicates a better outcome.
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Timepoint [16]
0
0
At 5 years chronological age
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Secondary outcome [17]
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Numerical Operations Standard Score
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Assessment method [17]
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Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Numerical Operations standard score
Minimum possible score: 45 Maximum possible score: 145
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
A higher score indicates a better outcome.
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Timepoint [17]
0
0
At 5 years chronological age
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Secondary outcome [18]
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Spelling Standard Score
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Assessment method [18]
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Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Spelling standard score
Minimum possible score: 45 Maximum possible score: 145
A higher score indicates a better outcome.
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [18]
0
0
At 5 years chronological age
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Secondary outcome [19]
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0
Numbers Total Scaled Score
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Assessment method [19]
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Children's Memory Scale (CMS):Numbers Total scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [19]
0
0
At 5 years chronological age
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Secondary outcome [20]
0
0
Word Lists 1 (Learning) Scaled Score
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Assessment method [20]
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Children's Memory Scale (CMS): Word Lists 1 (learning) scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [20]
0
0
At 5 years chronological age
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Secondary outcome [21]
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0
Memory and Learning Word Lists II (Delayed) Scaled Score
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Assessment method [21]
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Children's Memory Scale (CMS): Memory and learning Word Lists II (delayed) scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
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Timepoint [21]
0
0
At 5 years chronological age
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Secondary outcome [22]
0
0
The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function
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Assessment method [22]
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Full title: The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function
Preschool Version Parent Form (BRIEF-P) to measure behavioural executive abilities.
Minimum possible score: 40 Maximum possible score: 110
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
A higher score indicates a worse outcome.
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Timepoint [22]
0
0
At 5 years chronological age
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Secondary outcome [23]
0
0
The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System
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Assessment method [23]
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0
Full title: The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System
- 2nd edition (ABAS-II) to measure the child's adaptive behavior.
Minimum possible score: 45 Maximum possible score: 145
A higher score indicates a better outcome.
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [23]
0
0
At 5 years chronological age
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Secondary outcome [24]
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0
Total Problems Score
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Assessment method [24]
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Child Behaviour Checklist Caregiver Questionnaire (CBCL): Total Problems Score to measure behavioural problems
Minimum possible score: 40 Maximum possible score: 100
A higher score indicates a worse outcome.
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [24]
0
0
At 5 years chronological age
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Secondary outcome [25]
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0
Internalising Problems T Score
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Assessment method [25]
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Child Behaviour Checklist Caregiver Questionnaire (CBCL): CBCL internalising problems T score
Minimum possible score: 40 Maximum possible score: 100
A higher score indicates a worse outcome.
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [25]
0
0
At 5 years chronological age
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Secondary outcome [26]
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0
Externalising Problems T Score
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Assessment method [26]
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Child Behaviour Checklist Caregiver Questionnaire (CBCL): externalising problems T score
Minimum possible score: 40 Maximum possible score: 100
A higher score indicates a worse outcome.
Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
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Timepoint [26]
0
0
At 5 years chronological age
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Secondary outcome [27]
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0
Speech or Language Interventions
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Assessment method [27]
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0
Speech or language issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [27]
0
0
At 5 years chronological age
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Secondary outcome [28]
0
0
Psychomotor Interventions
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Assessment method [28]
0
0
Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [28]
0
0
At 5 years chronological age
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Secondary outcome [29]
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0
Number of Participants With Global Developmental Delay
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Assessment method [29]
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Child has global developmental delay. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [29]
0
0
At 5 years chronological age
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Secondary outcome [30]
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0
Number of Participants With Attention Deficit Hyperactivity Disorder
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Assessment method [30]
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Child has been diagnosed with Attention Deficit Hyperactivity Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [30]
0
0
At 5 years chronological age
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Secondary outcome [31]
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0
Number of Participants With Autism Spectrum Disorder
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Assessment method [31]
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0
Child has been diagnosis with Autism Spectrum Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [31]
0
0
At 5 years chronological age
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Secondary outcome [32]
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0
Number of Participants With a Hearing Abnormality
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Assessment method [32]
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0
Child has a hearing abnormality. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [32]
0
0
At 5 years chronological age
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Secondary outcome [33]
0
0
Number of Participants With a Visual Defect in Either Eye
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Assessment method [33]
0
0
Child has a visual defect in either eye. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [33]
0
0
At 5 years chronological age
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Secondary outcome [34]
0
0
Number of Participants With a Hearing Aid
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Assessment method [34]
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0
Child has a hearing aid. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [34]
0
0
At 5 years chronological age
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Secondary outcome [35]
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0
Number of Participants Who Are Legally Blind
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Assessment method [35]
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0
Child is legally blind. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [35]
0
0
At 5 years chronological age
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Secondary outcome [36]
0
0
Number of Participants Who Have Cerebral Palsy
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Assessment method [36]
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0
Child has cerebral palsy. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [36]
0
0
At 5 years chronological age
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Secondary outcome [37]
0
0
Parents' Awareness of Group Allocation
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Assessment method [37]
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0
Whether or not a parent is aware of which treatment group their child was allocated to. This variable will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [37]
0
0
At 5 years chronological age
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Secondary outcome [38]
0
0
Awareness of Group Allocation by Psychologist
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Assessment method [38]
0
0
These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
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Timepoint [38]
0
0
At 5 years chronological age
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Secondary outcome [39]
0
0
Awareness of Group Allocation by Pediatrician
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Assessment method [39]
0
0
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Timepoint [39]
0
0
At 5 years chronological age
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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)
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Minimum age
No limit
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Maximum age
60
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/10/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2018
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Sample size
Target
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Accrual to date
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Final
643
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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0
Adelaide Women's and Children's Hospital - North Adelaide
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Recruitment hospital [2]
0
0
Casey Hospital - Berwick
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Recruitment hospital [3]
0
0
Monash Medical Centre - Clayton
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Recruitment hospital [4]
0
0
Cabrini Hospital - Malvern
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Recruitment hospital [5]
0
0
Royal Children's Hospital - Parkville
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Recruitment hospital [6]
0
0
Princess Margaret Hospital - Perth
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Recruitment postcode(s) [1]
0
0
5006 - North Adelaide
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Recruitment postcode(s) [2]
0
0
3806 - Berwick
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Recruitment postcode(s) [3]
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0
3165 - Clayton
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Recruitment postcode(s) [4]
0
0
3144 - Malvern
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Recruitment postcode(s) [5]
0
0
3052 - Parkville
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Recruitment postcode(s) [6]
0
0
6008 - Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Colorado
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Illinois
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Iowa
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Massachusetts
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New Hampshire
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Pennsylvania
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Tennessee
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Texas
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Vermont
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Washington
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Country [11]
0
0
Canada
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State/province [11]
0
0
Quebec
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Country [12]
0
0
Italy
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State/province [12]
0
0
Bergamo
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Country [13]
0
0
Italy
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State/province [13]
0
0
Genoa
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Country [14]
0
0
Italy
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State/province [14]
0
0
Milano
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Country [15]
0
0
Netherlands
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State/province [15]
0
0
Groningen
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Country [16]
0
0
Netherlands
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State/province [16]
0
0
Utrecht
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Country [17]
0
0
New Zealand
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State/province [17]
0
0
Auckland
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Country [18]
0
0
United Kingdom
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State/province [18]
0
0
Belfast
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Country [19]
0
0
United Kingdom
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State/province [19]
0
0
Birmingham
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Country [20]
0
0
United Kingdom
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State/province [20]
0
0
Bristol
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Country [21]
0
0
United Kingdom
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State/province [21]
0
0
Glasgow
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Country [22]
0
0
United Kingdom
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State/province [22]
0
0
Liverpool
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Country [23]
0
0
United Kingdom
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State/province [23]
0
0
Sheffield
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Funding & Sponsors
Primary sponsor type
Other
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Name
Boston Children's Hospital
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
Royal Children's Hospital
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Other
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Name [2]
0
0
Royal Hospital for Sick Children
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Address [2]
0
0
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Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
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Name [3]
0
0
Murdoch Childrens Research Institute
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Address [3]
0
0
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Country [3]
0
0
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Other collaborator category [4]
0
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Government body
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Summary
Brief summary
The primary purpose of the GAS study is to determine whether different types of anesthesia
(Regional versus General) given to 720 infants undergoing inguinal hernia repair results in
equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of
apnea in the post-operative period after both regional and general anesthesia for inguinal
hernia repair in infants. This study is important as it will provide the greatest evidence
for safety or toxicity of general anesthesia for human infants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00756600
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Trial related presentations / publications
Davidson A, McCann ME, Morton N. Anesthesia neurotoxicity in neonates: the need for clinical research. Anesth Analg. 2007 Sep;105(3):881-2. doi: 10.1213/01.ane.0000269692.57331.48. No abstract available.
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Public notes
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Contacts
Principal investigator
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Andrew Davidson, MD
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Royal Children's Hospital, Victoria, Australia
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00756600
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