Neurodevelopmental outcome at two years of age after general and awake-regional anaesthesia in infancy: a randomised controlled trial methods
Aim. Evidence-backed execution summary for Neurodevelopmental outcome at two years of age after general and awake-regional anaesthesia in infancy: a randomised controlled trial methods from Neurodevelopmental outcome at two years of age after general and awake-regional anaesthesia in infancy: a randomised controlled trial.
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human
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Procedures
reagent used in the protocol.
- Use
- Serum glucose was measured after anesthetic induction. There were rescue protocols for hypoglycaemia, hypotension and hypoxemia. If the blood pressure fell >20% below baseline an intravenous bolus fluid was administered and vasoactive drugs given if deemed necessary. Hypoglycaemia (blood sugar <3·0mmol/L) was t...
Statistical Analysis
Risk ratios with 95% confidence intervals were reported for the proportion of individuals that fall below one and two SDs of the composite cognitive score. Risk ratios were generated using generalized linear models for a binomial distributed response variable employing a log link (binomial log-linear regression). Th...
- Use
- Risk ratios with 95% confidence intervals were reported for the proportion of individuals that fall below one and two SDs of the composite cognitive score. Risk ratios were generated using generalized linear models for a binomial distributed response variable employing a log link (binomial log-linear regression). Th...
Statistical Analysis
Software used for acquisition, scoring, statistics, or reporting.
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- Risk ratios with 95% confidence intervals were reported for the proportion of individuals that fall below one and two SDs of the composite cognitive score. Risk ratios were generated using generalized linear models for a binomial distributed response variable employing a log link (binomial log-linear regression). Th...
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Methods
We performed an international assessor-masked randomised controlled equivalence trial in infants less than 60 weeks post-menstrual age, born at greater than 26 weeks gestational age having inguinal herniorrhaphy. Infants were excluded if they had existing risk factors for neurologic injury. Infants were randomly assigned to awake-regional (RA) or sevoflurane-based general anaesthesia (GA). Web-based randomisation was performed in blocks of two or four and stratified by site and gestational age at birth. The outcome for analysis was the composite cognitive score of the Bayley Scales of Infant and Toddler Development, Third Edition. The analysis was as-per-protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. The trial was registered at ANZCTR, ACTRN12606000441516 and ClinicalTrials.gov, NCT00756...
Participants
Eligibility criteria included infants up to 60 weeks' postmenstrual age scheduled for unilateral or bilateral inguinal herniorraphy born at greater than 26 weeks gestation. Exclusion criteria included any contraindication for either anaesthetic technique, a history of congenital heart disease requiring surgery or pharmacotherapy, mechanical ventilation immediately prior to surgery, known chromosomal abnormalities or other known acquired or congenital abnormalities which might affect neurodevelopment, previous exposure to volatile GA or benzodiazepines as a neonate or in the third trimester in utero, any known neurologic injury such as cystic peri-ventricular leukomalacia or grade three or four intra-ventricular haemorrhage (IVH), any social or geographic factor that may make follow up difficult (such as planned house move, homelessness, no telephone communication available), or...
Randomisation and Masking
A 24-hour web-based randomisation service was managed by The Data Management & Analysis Centre, Department of Public Health, University of Adelaide, South Australia. Participants were randomised with a 1:1 allocation ratio to either GA or RA. Randomisation was performed in blocks of two or four and stratified by site and gestational age at birth: 26 to 29 weeks and six days, 30 to 36 weeks and six days and 37 weeks or more. The anaesthetist was aware of group allocation. Parents were not informed of the group allocation but were told if they asked. The psychologists and paediatricians performing the assessment were masked to group allocation. Once their assessment was completed they were asked to indicate if they were aware of group allocation.
Procedures
The RA group received either an awake-spinal anaesthetic, an awake-caudal anaesthetic, or a combined spinal-caudal anaesthetic according to institutional protocols. Spinal anaesthesia was performed with 0·2 ml/kg 0·5% isobaric bupivacaine with a minimum volume of 0·5ml. Due to unavailability of isobaric bupivacaine at some sites other agents were used (in the US, 0·13ml/kg of hyperbaric 0·75% bupivacaine and in the UK 0·2 ml/kg 0·5% levobupivacaine). Caudal anaesthesia was performed with up to a total dose of 2·5 mg.kg -1 of 0·25% bupivacaine. In the UK 0·25% levobupivacaine was used. In the US if surgery was likely to take greater than one hour, some patients were given a loading dose of 3% chloroprocaine (1ml/kg in divided doses of no more than 0·25ml/kg per 15 seconds) via a caudal cannula and then an infusion of 1-...
Procedures
Serum glucose was measured after anesthetic induction. There were rescue protocols for hypoglycaemia, hypotension and hypoxemia. If the blood pressure fell >20% below baseline an intravenous bolus fluid was administered and vasoactive drugs given if deemed necessary. Hypoglycaemia (blood sugar <3·0mmol/L) was treated with a bolus of 5ml/kg of 10% dextrose. Oxygen by face mask in the RA arm and an increased FiO 2 in the GA arm was used at the discretion of the anaesthetist to maintain arterial oxygen saturation > 95%.
Two Year Assessments
Assessments were performed within two months either side of two years of age (corrected for prematurity). The assessment took approximately two hours to complete. A trained psychologist administered the Bayley-III. The Bayley-III has cognitive, language and motor scales. The cognitive scale includes tasks assessing attention, memory, sensorimotor development, exploration, concept formation, and simple problem solving. The language scale assesses expressive and receptive skills, and the motor scale assesses fine and gross motor skills. Parents completed the Bayley-III Social-Emotional and Adaptive Behavior Questionnaires and the MacArthur-Bates Communicative Development Inventory: Words and Sentences (MacArthur-Bates). The MacArthur-Bates is a parent informant measure that assesses expressive language in children aged 16-30 months of age. Demographic data, family history, and med...
Statistical Analysis
Since this is an equivalence study, the outcome was analysed on an APP basis to ensure a conservative estimate in the direction of non-equivalence. Equivalence was defined a-priori if the 95% confidence interval of the difference in means lies within -five and +five points. ITT analyses were also planned. Analyses were adjusted for categories of gestational age at birth (182-209 days; 210-258 days; ≥259 days)
Statistical Analysis
Multiple imputation using chained equations was used to impute missing outcome data in the analysis of all outcomes. The following pre-specified variables were used as predictor variables within the imputation approach: anaesthesia group, country, gender, gestational age at birth, standardized z-score for birth weight, mother received antenatal steroids, mother diagnosed with chorioamnionitis, IVH, maternal age, maternal education, rescue glucose given intra-venously, need for fluid bolus for hypotension, vasoactive drugs given for hypotension, duration of surgery, dose of sevoflurane (concentration x hours), significant post-operative apnoea, corrected age at assessment, any more anaesthetic exposures since the inguinal herniorraphy, any malformations, any chronic illness, any prescribed medication for two months or longer, total length of any readmission to hospital, any interventio...
Measurement outputs
What raw and processed outputs should exist?
We performed an international assessor-masked randomised controlled equivalence trial in infants less than 60 weeks post-menstrual age, born at greater than 26 weeks gestational...
- Raw artifact
- Per-sample or per-animal endpoint measurements collected during the experiment
- Processed artifact
- Structured table with cleaned measurements ready for comparison
- Reported as
- Summary statistics and between-group or across-timepoint comparisons
For this secondary outcome we found no evidence that just under an hour of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at two yea...
- Raw artifact
- Per-sample or per-animal endpoint measurements collected during the experiment
- Processed artifact
- Structured table with cleaned measurements ready for comparison
- Reported as
- Summary statistics and between-group or across-timepoint comparisons
A 24-hour web-based randomisation service was managed by The Data Management & Analysis Centre, Department of Public Health, University of Adelaide, South Australia. Participant...
- Raw artifact
- Per-sample or per-animal endpoint measurements collected during the experiment
- Processed artifact
- Structured table with cleaned measurements ready for comparison
- Reported as
- Summary statistics and between-group or across-timepoint comparisons
Assessments were performed within two months either side of two years of age (corrected for prematurity). The assessment took approximately two hours to complete. A trained psyc...
- Raw artifact
- Per-sample or per-animal endpoint measurements collected during the experiment
- Processed artifact
- Structured table with cleaned measurements ready for comparison
- Reported as
- Summary statistics and between-group or across-timepoint comparisons
Analysis plan
How should the outputs become interpretable results?
Acquisition
Collect raw experimental outputs with enough metadata to preserve sample identity, condition, and timing.
inferred from protocolPreprocessing / cleaning
The main outcome for the analysis at 2 years of age was pre-specified to be the composite cognitive score of the Bayley-III.
from paperScoring or quantification
Quantify the primary readouts for this experiment: We performed an international assessor-masked randomised controlled equivalence trial in infants less than 60 weeks post-menstrual age, born at greater than 26 weeks gestational...; For this secondary outcome we found no evidence that just under an hour of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at two yea...; A 24-hour web-based randomisation service was managed by The Data Management & Analysis Centre, Department of Public Health, University of Adelaide, South Australia. Participant...; Assessments were performed within two months either side of two years of age (corrected for prematurity). The assessment took approximately two hours to complete. A trained psyc....
from paperStatistical comparison
The main outcome for the analysis at 2 years of age was pre-specified to be the composite cognitive score of the Bayley-III. The hypothesis (as stated in the protocol) was that...; Since this is an equivalence study, the outcome was analysed on an APP basis to ensure a conservative estimate in the direction of non-equivalence. Equivalence was defined a-pri...; The sample size was based on the primary outcome for the GAS trial; the five year follow up WPPSI-III Full Scale IQ score. Assuming an expected difference of one standardised sc...; Multiple imputation using chained equations was used to impute missing outcome data in the analysis of all outcomes. The following pre-specified variables were used as predictor...
from paperReporting output
Report representative outputs alongside summary comparisons for We performed an international assessor-masked randomised controlled equivalence trial in infants less than 60 weeks post-menstrual age, born at greater than 26 weeks gestational..., For this secondary outcome we found no evidence that just under an hour of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at two yea..., A 24-hour web-based randomisation service was managed by The Data Management & Analysis Centre, Department of Public Health, University of Adelaide, South Australia. Participant..., Assessments were performed within two months either side of two years of age (corrected for prematurity). The assessment took approximately two hours to complete. A trained psyc....
inferred from protocolStructured statistical methods
The main outcome for the analysis at 2 years of age was pre-specified to be the composite cognitive score of the Bayley-III. The hypothesis (as stated in the protocol) was that...; Since this is an equivalence study, the outcome was analysed on an APP basis to ensure a conservative estimate in the direction of non-equivalence. Equivalence was defined a-pri...; The sample size was based on the primary outcome for the GAS trial; the five year follow up WPPSI-III Full Scale IQ score. Assuming an expected difference of one standardised sc...; Multiple imputation using chained equations was used to impute missing outcome data in the analysis of all outcomes. The following pre-specified variables were used as predictor...
source structuredSource and audit
What supports the facts on this page?
Evidence quotes (8)
We performed an international assessor-masked randomised controlled equivalence trial in infants less than 60 weeks post-menstrual age, born at greater than 26 weeks gestational age having inguinal herniorrhaphy. Infants were excluded if they had existing risk factors for neurologic injury. Infants were randomly assigned to awake-regional (RA) or sevoflurane-based general anaesthesia (GA). Web-based randomisation was performed in blocks of two or four and stratified by site and gestational age at birth. The outcome for analysis was the composite cognitive score of the Bayley Scales of Infant and Toddler Development, Third Edition. The analysis was as-per-protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. The trial was registered at ANZCTR, ACTRN12606000441516 and ClinicalTrials.gov, NCT00756600.
Eligibility criteria included infants up to 60 weeks' postmenstrual age scheduled for unilateral or bilateral inguinal herniorraphy born at greater than 26 weeks gestation. Exclusion criteria included any contraindication for either anaesthetic technique, a history of congenital heart disease requiring surgery or pharmacotherapy, mechanical ventilation immediately prior to surgery, known chromosomal abnormalities or other known acquired or congenital abnormalities which might affect neurodevelopment, previous exposure to volatile GA or benzodiazepines as a neonate or in the third trimester in utero, any known neurologic injury such as cystic peri-ventricular leukomalacia or grade three or four intra-ventricular haemorrhage (IVH), any social or geographic factor that may make follow up difficult (such as planned house move, homelessness, no telephone communication available), or having a primary language at home in a region where neurodevelopmental tests are not available in that language. Eligible infants were identified from operating room schedules or at pre-admission clinics and recruited in the clinic or in the preadmission areas of the operating floor.
A 24-hour web-based randomisation service was managed by The Data Management & Analysis Centre, Department of Public Health, University of Adelaide, South Australia. Participants were randomised with a 1:1 allocation ratio to either GA or RA. Randomisation was performed in blocks of two or four and stratified by site and gestational age at birth: 26 to 29 weeks and six days, 30 to 36 weeks and six days and 37 weeks or more. The anaesthetist was aware of group allocation. Parents were not informed of the group allocation but were told if they asked. The psychologists and paediatricians performing the assessment were masked to group allocation. Once their assessment was completed they were asked to indicate if they were aware of group allocation.
The RA group received either an awake-spinal anaesthetic, an awake-caudal anaesthetic, or a combined spinal-caudal anaesthetic according to institutional protocols. Spinal anaesthesia was performed with 0·2 ml/kg 0·5% isobaric bupivacaine with a minimum volume of 0·5ml. Due to unavailability of isobaric bupivacaine at some sites other agents were used (in the US, 0·13ml/kg of hyperbaric 0·75% bupivacaine and in the UK 0·2 ml/kg 0·5% levobupivacaine). Caudal anaesthesia was performed with up to a total dose of 2·5 mg.kg -1 of 0·25% bupivacaine. In the UK 0·25% levobupivacaine was used. In the US if surgery was likely to take greater than one hour, some patients were given a loading dose of 3% chloroprocaine (1ml/kg in divided doses of no more than 0·25ml/kg per 15 seconds) via a caudal cannula and then an infusion of 1-2 ml/kg/hr. Ilioinguinal and field blocks could also be done. The total dose of bupivacaine did not exceed 2·5 mg/kg. In the RA group oral sucrose was used to settle the child if required and all other forms of sedation avoided. If the RA was ineffective then a GA was performed with sevoflurane...
Serum glucose was measured after anesthetic induction. There were rescue protocols for hypoglycaemia, hypotension and hypoxemia. If the blood pressure fell >20% below baseline an intravenous bolus fluid was administered and vasoactive drugs given if deemed necessary. Hypoglycaemia (blood sugar <3·0mmol/L) was treated with a bolus of 5ml/kg of 10% dextrose. Oxygen by face mask in the RA arm and an increased FiO 2 in the GA arm was used at the discretion of the anaesthetist to maintain arterial oxygen saturation > 95%.
Assessments were performed within two months either side of two years of age (corrected for prematurity). The assessment took approximately two hours to complete. A trained psychologist administered the Bayley-III. The Bayley-III has cognitive, language and motor scales. The cognitive scale includes tasks assessing attention, memory, sensorimotor development, exploration, concept formation, and simple problem solving. The language scale assesses expressive and receptive skills, and the motor scale assesses fine and gross motor skills. Parents completed the Bayley-III Social-Emotional and Adaptive Behavior Questionnaires and the MacArthur-Bates Communicative Development Inventory: Words and Sentences (MacArthur-Bates). The MacArthur-Bates is a parent informant measure that assesses expressive language in children aged 16-30 months of age. Demographic data, family history, and medical history were also noted, and a brief physical and neurological examination was performed. The physical examination included anthropometric measurements such as length, weight, arm and head circumference. The neurologic examination included cranial nerve examination, posture assessment and the m...
Since this is an equivalence study, the outcome was analysed on an APP basis to ensure a conservative estimate in the direction of non-equivalence. Equivalence was defined a-priori if the 95% confidence interval of the difference in means lies within -five and +five points. ITT analyses were also planned. Analyses were adjusted for categories of gestational age at birth (182-209 days; 210-258 days; ≥259 days)
Multiple imputation using chained equations was used to impute missing outcome data in the analysis of all outcomes. The following pre-specified variables were used as predictor variables within the imputation approach: anaesthesia group, country, gender, gestational age at birth, standardized z-score for birth weight, mother received antenatal steroids, mother diagnosed with chorioamnionitis, IVH, maternal age, maternal education, rescue glucose given intra-venously, need for fluid bolus for hypotension, vasoactive drugs given for hypotension, duration of surgery, dose of sevoflurane (concentration x hours), significant post-operative apnoea, corrected age at assessment, any more anaesthetic exposures since the inguinal herniorraphy, any malformations, any chronic illness, any prescribed medication for two months or longer, total length of any readmission to hospital, any interventions for neurodevelopmental problems, diagnosis of cerebral palsy, any other neurological abnormality.
Machine-readable layer
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