N/A
N=89
The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)
Anesthesia; Adverse Effect · Congenital Heart Disease · Neurodevelopmental Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03882788 ↗Enrolled (actual)
89
Serious AEs
19.1%
Results posted
May 2022
Primary outcome: Primary: Bayley III — 91; 93; 88; 90 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Isoflurane (Drug); Fentanyl (high dose) (Drug); Fentanyl (low dose) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bayley III |
91; 93; 88; 90; 97; 90 | — |
| PRIMARY Electroencephalogram |
0; 0; 1; 1; 0; 1 | — |
| SECONDARY Choline |
— | — |
| SECONDARY Glutamate |
— | — |
| SECONDARY N-acetylaspartate (Naa) |
— | — |
| SECONDARY Lactate |
— | — |
Summary
The purpose of this study is to assess whether the type of anesthesia, narcotic-based versus inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes to the wide variation in neurologic recovery and developmental outcome after surgery in infants with congenital heart disease.
Eligibility Criteria
Inclusion Criteria
- Neonates of at least 32 weeks of gestation, infants and children up to 2 years of age admitted to The Children's Hospital for treatment of cyanotic or non-cyanotic heart disease requiring surgical intervention.
- Admitting diagnosis of cyanotic or non-cyanotic heart disease
Exclusion Criteria
- Neonates less than 32 weeks of gestational age, and children more than 2 years of age.
- Any documented central nervous system malformations.
- Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support
Data sourced from ClinicalTrials.gov (NCT03882788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.