Trial Outcomes & Findings for The Effect of Anesthesia on Neurodevelopmental Outcome (NDO) (NCT NCT03882788)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

153 participants

Primary outcome timeframe

Assessed once between age 18 to 48 months (approximately 2 hours to assess), up to 48 months from study start

Results posted on

2022-05-09

Participant Flow

Randomization data are available for only 89 of the 153 participants enrolled.

Participant milestones

Participant milestones
Measure	Narcotic Based Anesthesia Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).	Volatile Anesthesia Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).
Overall Study STARTED	44	45
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Narcotic Based Anesthesia n=44 Participants Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).	Volatile Anesthesia n=45 Participants Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).	Total n=89 Participants Total of all reporting groups
Age, Continuous	8.1 months STANDARD_DEVIATION 8.5 • n=5 Participants	6.2 months STANDARD_DEVIATION 8.5 • n=7 Participants	7.1 months STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Highlander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed once between age 18 to 48 months (approximately 2 hours to assess), up to 48 months from study start

Population: Participants with a completed Bayley III assessment are included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Narcotic Based Anesthesia n=10 Participants Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).	Volatile Anesthesia n=18 Participants Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).
Bayley III Cognitive Standard Score	91 score on a scale Standard Deviation 10	93 score on a scale Standard Deviation 15
Bayley III Language Standard Score	88 score on a scale Standard Deviation 11	90 score on a scale Standard Deviation 18
Bayley III Motor Standard Score	97 score on a scale Standard Deviation 13	90 score on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Narcotic Based Anesthesia n=44 Participants Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).	Volatile Anesthesia n=45 Participants Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).
Electroencephalogram Abnormal preoperative EEG	0 Participants	0 Participants
Electroencephalogram Abnormal intraoperative EEG	1 Participants	1 Participants
Electroencephalogram Abnormal EEG in CVICU	0 Participants	1 Participants
Electroencephalogram Abnormal EEG predischarge	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-72 hours

Population: Data were not collected for this outcome measure.

blood levels: time and patient dependent variation, observed patient related trends over time

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-72 hours

Population: Data were not collected for this outcome measure.

blood levels:time and patient dependent variation, observed patient related trends over time

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-72 hours

Population: Data were not collected for this outcome measure.

blood levels:time and patient dependent variation, observed patient related trends over time

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-72 hours

Population: Data were not collected for this outcome measure.

blood levels:time and patient dependent variation, observed patient related trends over time

Outcome measures

Outcome data not reported

Adverse Events

Narcotic Based Anesthesia

Serious events: 7 serious events

Other events: 0 other events

Deaths: 3 deaths

Volatile Anesthesia

Serious events: 10 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Narcotic Based Anesthesia n=44 participants at risk Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).	Volatile Anesthesia n=45 participants at risk Participants receive volatile anesthetic isoflurane (1.5-2.0%) as primary anesthetic; participants also receive rocuronium or pancuronium for muscle relaxation, and fentanyl at no greater than 2 mcg/kg/hr (low dose).
Cardiac disorders Cardiopulmonary arrest	0.00% 0/44 • 48 months Participants with randomization data are included in the analysis.	4.4% 2/45 • 48 months Participants with randomization data are included in the analysis.
Cardiac disorders Hypotension	2.3% 1/44 • 48 months Participants with randomization data are included in the analysis.	4.4% 2/45 • 48 months Participants with randomization data are included in the analysis.
Cardiac disorders Arrythmia	9.1% 4/44 • 48 months Participants with randomization data are included in the analysis.	6.7% 3/45 • 48 months Participants with randomization data are included in the analysis.
Vascular disorders Bleeding	4.5% 2/44 • 48 months Participants with randomization data are included in the analysis.	2.2% 1/45 • 48 months Participants with randomization data are included in the analysis.
Blood and lymphatic system disorders Sepsis	0.00% 0/44 • 48 months Participants with randomization data are included in the analysis.	2.2% 1/45 • 48 months Participants with randomization data are included in the analysis.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/44 • 48 months Participants with randomization data are included in the analysis.	2.2% 1/45 • 48 months Participants with randomization data are included in the analysis.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trials Manager

Research Office

Phone: 650-724-1720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place