Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05673499




Registration number
NCT05673499
Ethics application status
Date submitted
21/12/2022
Date registered
6/01/2023
Date last updated
15/04/2024

Titles & IDs
Public title
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Scientific title
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Secondary ID [1] 0 0
22-019679
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Disorders 0 0
Cerebral Desaturation 0 0
Neonatal Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - NIRS/EEG monitoring

Infants - Infant subjects = 60 weeks post-menstrual age who are undergoing surgery for congenital malformations


Treatment: Devices: NIRS/EEG monitoring
The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with perioperative cerebral desaturation
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
Isoelectric EEG
Timepoint [1] 0 0
up to 24 hours
Secondary outcome [2] 0 0
Perioperative outcomes
Timepoint [2] 0 0
up to 100 days

Eligibility
Key inclusion criteria
1. Infants = 60 weeks post-menstrual age on day of surgery.
2. Neonatal surgery for congenital abdominal/gastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid/pulmonary airway malformation (CCAM/CPAM), esophageal/tracheoesophageal fistula (EF/TEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma).
3. The same patient may be enrolled multiple times for repeat or different procedures that meet the above criteria. These subjects will be counted more than once towards the enrollment goal.
4. Parental/guardian permission.
Minimum age
No limit
Maximum age
60 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment postcode(s) [2] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Brazil
State/province [4] 0 0
São Paulo
Country [5] 0 0
China
State/province [5] 0 0
Guangzhou
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
China
State/province [7] 0 0
Shenyang
Country [8] 0 0
China
State/province [8] 0 0
Sichuan
Country [9] 0 0
France
State/province [9] 0 0
Bordeaux
Country [10] 0 0
India
State/province [10] 0 0
Chandigarh
Country [11] 0 0
India
State/province [11] 0 0
Vellore
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Hospital of Philadelphia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Masimo Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Yuan, MD
Address 0 0
Children's Hospital of Philadelphia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paula Hu, RN, MSPH
Address 0 0
Country 0 0
Phone 0 0
267-426-2961
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05673499