Infant Clinical Trial
— GENIUSOfficial title:
General Anesthesia Exposed Infants Neurodevelopment Investigation: a Multi-center Prospective Cohort Study United in Shanghai
NCT number | NCT03629093 |
Other study ID # | GENIUS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | December 30, 2024 |
Numerous preclinical evidence has confirmed that most commonly-used general anesthetics can affect neurodevelopment of young animals adversely, causing both structural defect of brain and cognitive impairment. However, it is unclear at present whether such effect would also occur to children exposed to general anesthesia in their early life. Several observational clinical studies and one interventional clinical trial indicated that short-time general anesthesia less than 80 minutes might be safe to cognitive development. Concerning long-time and/or multiple anesthesia exposure, some studies supported its association with long-term cognitive defects, while other studies did not. These studies are mainly retrospective or ambirectional researches. We have designed a prospective, multicenter cohort study to examine the neurodevelopment of infants exposed to anesthesia before age 2 in the first year after surgery, and compare the neurodevelopment status of infants exposed to anesthesia less than 3 hours and those more than 3 hours. The Gesell Developmental Inventory (GDI) and several neuropsychological testing batteries will be used. The anticipated outcome of the study will add reliable evidence from Asians to elucidate the relationship of anesthesia and long-term neurodevelopment of infants.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Years |
Eligibility | Inclusion Criteria: - Apgar score = 8 at birth - ASA level ?~? - Obtained written consent form from the infants' parents or guardians Exclusion Criteria: - Postmenstrual age = 44 weeks, or postmenstrual age = 144 weeks - Severe cardiac, pulmonary, or neurologic disease - Severe obstructive sleep apnea hypopnea syndrome - History of dystocia and/or hypoxic ischemic encephalopathy - Gestational age at birth =32 weeks - Any known or suspected chromosomal abnormalities, abnormal development of vision or hearing, neurodevelopment retardation, or other known acquired or congenital abnormalities that might affect neurodevelopment - Significant cardiovascular surgery, significant ENT surgery, or neurosurgery - Malignant diseases that may reduce survival - Taking part in other clinical trials in the last 3 months or at present |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital | Children's Hospital of Fudan University, Shanghai Children's Hospital, Shanghai Children's Medical Center, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4. Erratum in: Lancet. 2016 Jan 16;387(10015):228. — View Citation
Graham MR. Clinical update regarding general anesthesia-associated neurotoxicity in infants and children. Curr Opin Anaesthesiol. 2017 Dec;30(6):682-687. doi: 10.1097/ACO.0000000000000520. Review. — View Citation
Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967. — View Citation
Warner DO, Zaccariello MJ, Katusic SK, Schroeder DR, Hanson AC, Schulte PJ, Buenvenida SL, Gleich SJ, Wilder RT, Sprung J, Hu D, Voigt RG, Paule MG, Chelonis JJ, Flick RP. Neuropsychological and Behavioral Outcomes after Exposure of Young Children to Procedures Requiring General Anesthesia: The Mayo Anesthesia Safety in Kids (MASK) Study. Anesthesiology. 2018 Jul;129(1):89-105. doi: 10.1097/ALN.0000000000002232. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the developmental quotient of the Gesell Developmental Inventory | The Gesell Developmental Inventory has been translated into Chinese and standardized by the Beijing Children's Health Care Institute and the performance results are expressed as a developmental quotient (DQ). | From baseline before anesthesia to 1 year after anesthesia | |
Secondary | Change of the standardized score of the five domains of the Gesell Developmental Inventory | The five behavioral domains are gross motor, fine motor, language, adaptive, and personal-social behaviors. | From baseline before anesthesia to 1 year after anesthesia | |
Secondary | Change of the standardized score of the Social Maturity Scale | The Social Maturity Scale includes six domains and 132 questions designed to be completed by the parents. | From baseline before anesthesia to 1 year after anesthesia |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01162798 -
Preterm Infant Growth
|
N/A | |
Completed |
NCT00808756 -
Study on Fermentable Carbohydrates in Healthy Infants
|
N/A | |
Completed |
NCT00355654 -
Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®
|
Phase 3 | |
Recruiting |
NCT06032494 -
Investigating Changes in Vital Signs in Neonates
|
||
Not yet recruiting |
NCT05914324 -
Outpatient Pediatric Pulse Oximeters in Africa
|
N/A | |
Completed |
NCT04523441 -
Early Support and Physiotherapy for Children and Their Motor Skills
|
||
Completed |
NCT02441296 -
Carbohydrate and Metabolism: a Pilot Study
|
N/A | |
Completed |
NCT01216709 -
Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)
|
N/A | |
Completed |
NCT00507676 -
Lung Function and Structure in Healthy Infants and Infants With Recurrent Wheezing
|
N/A | |
Recruiting |
NCT05072626 -
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
|
||
Completed |
NCT04536194 -
Dopamine Versus Norepinephrine Under General Anesthesia
|
Phase 3 | |
Recruiting |
NCT04598061 -
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
|
||
Completed |
NCT03567031 -
Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
|
N/A | |
Completed |
NCT02366780 -
Breast Milk Content Expressed Manually Compared to Electric Pump
|
N/A | |
Terminated |
NCT04641000 -
The Alberta BLOOM Long Term Follow Up Study
|
||
Completed |
NCT02580123 -
Smile-Kids: Study on Complementary Feeding Transition
|
N/A | |
Completed |
NCT00294294 -
Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa
|
Phase 4 | |
Recruiting |
NCT04967118 -
Neonatal Pain Management and Pain Monitoring Using New Methods
|
N/A | |
Completed |
NCT03025178 -
Optimal Insertion Depth of Left Internal Jugular Vein Catheter in Infants
|
N/A | |
Completed |
NCT02722759 -
Haemoglobin Measurement for Babies
|
N/A |