Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Royal Children's Hospital | OTHER |
| Royal Hospital for Sick Children | OTHER |
| Murdoch Childrens Research Institute | OTHER |
| Food and Drug Administration (FDA) |
Not provided
Not provided
Not provided
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.
This is a prospective, observer blind, multi-site, randomized, controlled, equivalence trial. The general anesthesia group will receive sevoflurane (intervention drug) 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 per kg) administered via caudal or ilioinguinal nerve block. The airway can be maintained with a face mask, laryngeal mask or endotracheal tube, with or without neuromuscular blocking agents.
The regional group will have no sedative agent. The regional blockade may be with spinal alone, spinal block with caudal block, spinal with ilioinguinal block or caudal alone. The maximum dose of 2.5 mg per kg of bupivacaine can be used.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Regional Anesthesia |
|
| 2 | Active Comparator | General Anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Anesthesia | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Full Scale IQ Score | 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. | At 5 years chronological age |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal IQ | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Davidson, MD | Royal Children's Hospital, Victoria, Australia | Principal Investigator |
| Mary Ellen McCann, MD | Children's Hospital Boston, United States of America | Principal Investigator |
| Neil Morton, MD | Royal Hospital for Sick Children, Glasgow, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital Denver | Aurora | Colorado | 80045 | United States | ||
| Children's Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17717261 | Background | 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. | |
| 30782342 | Derived | McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14. |
Not provided
Not provided
There are no significant events that occur after enrollment and before randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Regional Anesthesia | 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. |
| FG001 | General Anesthesia |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2020 |
Not provided
| FED |
Not provided
Not provided
Not provided
Not provided
|
| General Anesthesia | Drug | 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. |
|
|
| At 5 years corrected age. |
| Performance IQ | 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. | At 5 years corrected age |
| Processing Speed Quotient | 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. | At 5 years corrected age |
| Sentence Repetition Scaled Score | 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. | At 5 years chronological age |
| Auditory Attention Combined Scaled Score | 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. | At 5 years corrected age |
| Statue Scaled Score | 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. | At 5 years corrected age |
| Inhibition Combined Scaled Score | 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. | At 5 years corrected age |
| Word Generation Scaled Score | 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. | At 5 years corrected age |
| Affect Recognition Scaled Score | 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. | At 5 years corrected age |
| Memory for Names and Memory for Names Delay | 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. | At 5 years corrected age |
| Theory of Mind Scaled Score | 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. | At 5 years corrected age |
| Speeded Naming Combined Scaled Score | 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. | At 5 years corrected age |
| Fingertip Tapping Repetitions Scaled Score | 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. | At 5 years corrected age |
| Fingertip Tapping Sequences Scaled Score | 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. | At 5 years corrected age |
| Design Copy Process Total Scaled Score | 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. | At 5 years corrected age |
| Word Reading Standard Score | 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. | At 5 years chronological age |
| Numerical Operations Standard Score | 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. | At 5 years chronological age |
| Spelling Standard Score | 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. | At 5 years chronological age |
| Numbers Total Scaled Score | Children's Memory Scale (CMS):Numbers Total scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. | At 5 years chronological age |
| Word Lists 1 (Learning) Scaled Score | 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. | At 5 years chronological age |
| Memory and Learning Word Lists II (Delayed) Scaled Score | 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. | At 5 years chronological age |
| The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function | 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. | At 5 years chronological age |
| The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System | 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. | At 5 years chronological age |
| Total Problems Score | 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. | At 5 years chronological age |
| Internalising Problems T Score | 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. | At 5 years chronological age |
| Externalising Problems T Score | 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. | At 5 years chronological age |
| Speech or Language Interventions | 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. | At 5 years chronological age |
| Psychomotor Interventions | Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. | At 5 years chronological age |
| Number of Participants With Global Developmental Delay | 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. | At 5 years chronological age |
| Number of Participants With Attention Deficit Hyperactivity Disorder | 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. | At 5 years chronological age |
| Number of Participants With Autism Spectrum Disorder | 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. | At 5 years chronological age |
| Number of Participants With a Hearing Abnormality | 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. | At 5 years chronological age |
| Number of Participants With a Visual Defect in Either Eye | 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. | At 5 years chronological age |
| Number of Participants With a Hearing Aid | 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. | At 5 years chronological age |
| Number of Participants Who Are Legally Blind | 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. | At 5 years chronological age |
| Number of Participants Who Have Cerebral Palsy | 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. | At 5 years chronological age |
| Parents' Awareness of Group Allocation | 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. | At 5 years chronological age |
| Awareness of Group Allocation by Psychologist | These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. | At 5 years chronological age |
| Awareness of Group Allocation by Pediatrician | At 5 years chronological age |
| Chicago |
| Illinois |
| 60614 |
| United States |
| The University of Iowa Hospital | Iowa City | Iowa | 52242 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37212 | United States |
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| Vermont Children's Hospital at Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Adelaide Women's and Children's Hospital | North Adelaide | South Australia | 5006 | Australia |
| Casey Hospital | Berwick | Victoria | 3806 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3165 | Australia |
| Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Princess Margaret Hospital | Perth | Western Australia | 6008 | Australia |
| Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Ospedali Riuniti Di Bergamo | Bergamo | 24100 | Italy |
| G. Gaslini Children's Hospital | Genoa | 16147 | Italy |
| 'Vitore Buzzi' Children's Hospital | Milan | 20100 | Italy |
| Universitair Medisch Centrum Groningen | Groningen | 9700 RB | Netherlands |
| Wilhelmina Children's Hospital; University Medical Centre Utrecht | Utrecht | Netherlands |
| Starship Children's Health | Auckland | New Zealand |
| Royal Belfast Hospital for Sick Children | Belfast | BT12 6BE | United Kingdom |
| Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
| Bristol Royal Hospital for Children | Bristol | BS2 8BJ | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | G3 8SJ | United Kingdom |
| Royal Liverpool Children's Hospital | Liverpool | L12 2APS | United Kingdom |
| Sheffield Children's Hospital | Sheffield | S10 2TS | United Kingdom |
| 26507180 | Derived | Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4. |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group were included in the published analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Regional Anesthesia | 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. |
| BG001 | General Anesthesia | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | days |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Full Scale IQ Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Verbal IQ | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age. |
|
| |||||||||||||||||||||||||||||
| Secondary | Performance IQ | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Processing Speed Quotient | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Sentence Repetition Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||
| Secondary | Auditory Attention Combined Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Statue Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Inhibition Combined Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Word Generation Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Affect Recognition Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Memory for Names and Memory for Names Delay | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Theory of Mind Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Speeded Naming Combined Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Fingertip Tapping Repetitions Scaled Score | 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. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Fingertip Tapping Sequences Scaled Score | 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. | Posted | Mean | Standard Deviation | score on scale | At 5 years corrected age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Design Copy Process Total Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on a scale | At 5 years corrected age |
|
| |||||||||||||||||||||||||||||
| Secondary | Word Reading Standard Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
| ||||||||||||||||||||||||||||||
| Secondary | Numerical Operations Standard Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
| ||||||||||||||||||||||||||||||
| Secondary | Spelling Standard Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
| ||||||||||||||||||||||||||||||
| Secondary | Numbers Total Scaled Score | Children's Memory Scale (CMS):Numbers Total scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||
| Secondary | Word Lists 1 (Learning) Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||
| Secondary | Memory and Learning Word Lists II (Delayed) Scaled Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||
| Secondary | The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
| ||||||||||||||||||||||||||||||
| Secondary | The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
| ||||||||||||||||||||||||||||||
| Secondary | Total Problems Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||
| Secondary | Internalising Problems T Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||
| Secondary | Externalising Problems T Score | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Mean | Standard Deviation | score on scale | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||
| Secondary | Speech or Language Interventions | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Psychomotor Interventions | Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Global Developmental Delay | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Attention Deficit Hyperactivity Disorder | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Autism Spectrum Disorder | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Hearing Abnormality | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Visual Defect in Either Eye | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Hearing Aid | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Are Legally Blind | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Have Cerebral Palsy | 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. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | Posted | Number | participants | At 5 years chronological age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Parents' Awareness of Group Allocation | 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. | Posted | Number | caregivers | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||||
| Secondary | Awareness of Group Allocation by Psychologist | These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. | Posted | Number | psychologists | At 5 years chronological age |
|
| |||||||||||||||||||||||||||||||
| Secondary | Awareness of Group Allocation by Pediatrician | Posted | Number | Pediatricians | At 5 years chronological age |
|
|
Adverse Events were not monitored/assessed
Adverse Events were not monitored/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regional Anesthesia | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | General Anesthesia | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mary Ellen McCann | Boston Children's Hospital Anesthesia Foundation | 6173557737 | mary.mccann@childrens.harvard.edu |
| Feb 27, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000775 | Anesthesia, Spinal |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
| Canada |
|
|
| Netherlands |
|
|
| United States |
|
|
| Italy |
|
|
| United Kingdom |
|
|
| Australia |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|