Trial · NCT03882788
The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)
NCT03882788, Not applicable, Completed, Stanford University; results first posted 2022-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Anesthesia on Neurodevelopmental Outcome (NDO). Trials, record NCT03882788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03882788
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)
- NCT number
- NCT03882788
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 153 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Anesthesia; Adverse Effect, Congenital Heart Disease, Neurodevelopmental Disorders
- Interventions
- Isoflurane, Fentanyl (high dose), Fentanyl (low dose)
- First posted
- 2019-03-20
- Last updated
- 2022-05-09
- Results first posted
- 2022-05-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bayley III | Assessed once between age 18 to 48 months (approximately 2 hours to assess), up to 48 months from study start | Neurodevelopmental assessment scores are age dependent and based motor and behavioral abilities, often reported for normal or abnormal for age. Bayley Scales of Infant and Toddler Development, third edition, (Bayley III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items, score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. |
| Primary | Electroencephalogram | EEG taken immediately prior to surgery, during surgery, during cardiovascular intensive care unit (CVICU) stay (up to 48 hours after surgery), and immediately prior to discharge (between 5 to 20 minutes to assess EEG at each time point) | Brain electrical activity: observation is for brain region specific abnormal or seizure activity. Number of participants with abnormal EEG are reported. |
| Secondary | Choline | 0-72 hours | blood levels: time and patient dependent variation, observed patient related trends over time |
| Secondary | Glutamate | 0-72 hours | blood levels:time and patient dependent variation, observed patient related trends over time |
| Secondary | N-acetylaspartate (Naa) | 0-72 hours | blood levels:time and patient dependent variation, observed patient related trends over time |
| Secondary | Lactate | 0-72 hours | blood levels:time and patient dependent variation, observed patient related trends over time |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bayley III | Assessed once between age 18 to 48 months (approximately 2 hours to assess), up to 48 months from study start | Participants with a completed Bayley III assessment are included in the analysis. | score on a scale | MEAN |
| PRIMARY | Electroencephalogram | EEG taken immediately prior to surgery, during surgery, during cardiovascular intensive care unit (CVICU) stay (up to 48 hours after surgery), and immediately prior to discharge (between 5 to 20 minutes to assess EEG at each time point) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Choline | 0-72 hours | Data were not collected for this outcome measure. | ||
| SECONDARY | Glutamate | 0-72 hours | Data were not collected for this outcome measure. | ||
| SECONDARY | N-acetylaspartate (Naa) | 0-72 hours | Data were not collected for this outcome measure. | ||
| SECONDARY | Lactate | 0-72 hours | Data were not collected for this outcome measure. |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bayley III | Narcotic Based Anesthesia | Cognitive Standard Score | 91 | Standard Deviation 10 | score on a scale |
| Bayley III | Volatile Anesthesia | Cognitive Standard Score | 93 | Standard Deviation 15 | score on a scale |
| Bayley III | Narcotic Based Anesthesia | Language Standard Score | 88 | Standard Deviation 11 | score on a scale |
| Bayley III | Volatile Anesthesia | Language Standard Score | 90 | Standard Deviation 18 | score on a scale |
| Bayley III | Narcotic Based Anesthesia | Motor Standard Score | 97 | Standard Deviation 13 | score on a scale |
| Bayley III | Volatile Anesthesia | Motor Standard Score | 90 | Standard Deviation 15 | score on a scale |
| Electroencephalogram | Narcotic Based Anesthesia | Abnormal preoperative EEG | 0 | Participants | |
| Electroencephalogram | Volatile Anesthesia | Abnormal preoperative EEG | 0 | Participants | |
| Electroencephalogram | Narcotic Based Anesthesia | Abnormal intraoperative EEG | 1 | Participants | |
| Electroencephalogram | Volatile Anesthesia | Abnormal intraoperative EEG | 1 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Narcotic Based Anesthesia | 44 | |
| Overall Study | STARTED | Volatile Anesthesia | 45 | |
| Overall Study | COMPLETED | Narcotic Based Anesthesia | 44 | |
| Overall Study | COMPLETED | Volatile Anesthesia | 45 | |
| Overall Study | NOT COMPLETED | Narcotic Based Anesthesia | 0 | |
| Overall Study | NOT COMPLETED | Volatile Anesthesia | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cardiopulmonary arrest | Cardiac disorders | Narcotic Based Anesthesia | 0 | 44 | |
| serious | Cardiopulmonary arrest | Cardiac disorders | Volatile Anesthesia | 2 | 45 | |
| serious | Hypotension | Cardiac disorders | Narcotic Based Anesthesia | 1 | 44 | |
| serious | Hypotension | Cardiac disorders | Volatile Anesthesia | 2 | 45 | |
| serious | Arrythmia | Cardiac disorders | Narcotic Based Anesthesia | 4 | 44 | |
| serious | Arrythmia | Cardiac disorders | Volatile Anesthesia | 3 | 45 | |
| serious | Bleeding | Vascular disorders | Narcotic Based Anesthesia | 2 | 44 | |
| serious | Bleeding | Vascular disorders | Volatile Anesthesia | 1 | 45 | |
| serious | Sepsis | Blood and lymphatic system disorders | Narcotic Based Anesthesia | 0 | 44 | |
| serious | Sepsis | Blood and lymphatic system disorders | Volatile Anesthesia | 1 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Narcotic Based Anesthesia | 3 | 44 |
| Total, all-cause mortality | Volatile Anesthesia | 1 | 45 |
| Total, other adverse events | Narcotic Based Anesthesia | 0 | 44 |
| Total, other adverse events | Volatile Anesthesia | 0 | 45 |
| Total, serious adverse events | Narcotic Based Anesthesia | 7 | 44 |
| Total, serious adverse events | Volatile Anesthesia | 10 | 45 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Narcotic Based Anesthesia vs Volatile Anesthesia: deaths from any cause | Trial comparisons |
| Narcotic Based Anesthesia vs Volatile Anesthesia: serious adverse events | 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/NCT03882788
GET https://conductscience.org/api/trials/v1/NCT03882788/registered