Trial · NCT00756600
A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
NCT00756600, Phase 4, Completed, Boston Children's Hospital; results first posted 2020-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants. Trials, record NCT00756600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00756600
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
- NCT number
- NCT00756600
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 643 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Inguinal Hernia
- Interventions
- Regional Anesthesia, General Anesthesia
- First posted
- 2008-09-22
- Last updated
- 2020-04-29
- Results first posted
- 2020-04-29
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Full Scale IQ Score | At 5 years chronological age | 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. |
| Secondary | Verbal IQ | At 5 years corrected age. | 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. |
| Secondary | Performance IQ | At 5 years corrected age | 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. |
| Secondary | Processing Speed Quotient | At 5 years corrected age | 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. |
| Secondary | Sentence Repetition Scaled Score | At 5 years chronological age | 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. |
| Secondary | Auditory Attention Combined Scaled Score | At 5 years corrected age | 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. |
| Secondary | Statue Scaled Score | At 5 years corrected age | 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. |
| Secondary | Inhibition Combined Scaled Score | At 5 years corrected age | 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. |
| Secondary | Word Generation Scaled Score | At 5 years corrected age | 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. |
| Secondary | Affect Recognition Scaled Score | At 5 years corrected age | 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. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Full Scale IQ Score | At 5 years chronological age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Verbal IQ | At 5 years corrected age. | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Performance IQ | At 5 years corrected age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Processing Speed Quotient | At 5 years corrected age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Sentence Repetition Scaled Score | At 5 years chronological age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Auditory Attention Combined Scaled Score | At 5 years corrected age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Statue Scaled Score | At 5 years corrected age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Inhibition Combined Scaled Score | At 5 years corrected age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Word Generation Scaled Score | At 5 years corrected age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
| SECONDARY | Affect Recognition Scaled Score | At 5 years corrected age | Not all participants had data collected for this Outcome Measure due to absence at follow up visit. | score on scale | MEAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Full Scale IQ Score | Regional Anesthesia | 100.5 | Standard Deviation 14.3 | score on scale | |
| Full Scale IQ Score | General Anesthesia | 100.1 | Standard Deviation 15.3 | score on scale | |
| Verbal IQ | Regional Anesthesia | 101.8 | Standard Deviation 14.7 | score on scale | |
| Verbal IQ | General Anesthesia | 100.9 | Standard Deviation 15.4 | score on scale | |
| Performance IQ | Regional Anesthesia | 100.7 | Standard Deviation 15.2 | score on scale | |
| Performance IQ | General Anesthesia | 101.2 | Standard Deviation 15.9 | score on scale | |
| Processing Speed Quotient | Regional Anesthesia | 95.8 | Standard Deviation 14.5 | score on scale | |
| Processing Speed Quotient | General Anesthesia | 96.3 | Standard Deviation 15.4 | score on scale | |
| Sentence Repetition Scaled Score | Regional Anesthesia | 9.7 | Standard Deviation 2.9 | score on scale | |
| Sentence Repetition Scaled Score | General Anesthesia | 9.7 | Standard Deviation 2.8 | score on scale |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regional Anesthesia | 287 | |
| Overall Study | STARTED | General Anesthesia | 356 | |
| Overall Study | COMPLETED | Regional Anesthesia | 287 | |
| Overall Study | COMPLETED | General Anesthesia | 356 | |
| Overall Study | NOT COMPLETED | Regional Anesthesia | 0 | |
| Overall Study | NOT COMPLETED | General Anesthesia | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regional Anesthesia | 0 | 0 |
| Total, all-cause mortality | General Anesthesia | 0 | 0 |
| Total, other adverse events | Regional Anesthesia | 0 | 0 |
| Total, other adverse events | General Anesthesia | 0 | 0 |
| Total, serious adverse events | Regional Anesthesia | 0 | 0 |
| Total, serious adverse events | General Anesthesia | 0 | 0 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Regional Anesthesia vs General Anesthesia: Number of Participants With Attention Deficit Hyperactivity Disorder | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Speech or Language Interventions | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Number of Participants Who Are Legally Blind | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Number of Participants With Global Developmental Delay | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Number of Participants With a Hearing Abnormality | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Number of Participants Who Have Cerebral Palsy | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Number of Participants With Autism Spectrum Disorder | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Number of Participants With a Hearing Aid | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Number of Participants With a Visual Defect in Either Eye | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Psychomotor Interventions | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00756600
GET https://conductscience.org/api/trials/v1/NCT00756600/registered?page=2