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NCT05673499 · ClinicalTrials.gov registry record
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
A clinical trial of Congenital Disorders and Cerebral Desaturation, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- 900
- Enrollment target
- 15
- Study locations
NCT05673499: Recruiting study of Congenital Disorders and Cerebral Desaturation, sponsored by Children's Hospital of Philadelphia.
NCT05673499 is a study of Congenital Disorders and Cerebral Desaturation that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 900 participants, above the 310-participant average among 4 other Congenital Disorders trials with a reported enrollment target (190% higher). The trial reports 15 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05673499, a study of Congenital Disorders and Cerebral Desaturation, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- 900 participants
- Enrollment target
- 15
- Study locations
Study Summary
The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1. The perioperative factors associated with occurrence of cerebral desaturation 2. The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions. Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.
Primary Outcome
The incidence of cerebral desaturation in participants will be assessed by the Near-infrared Spectroscopy (NIRS) data recording of \<70% and/or \>10% decrease from baseline for \> 3 minutes
Conditions Studied
Interventions
- DEVICE NIRS/EEG monitoring
Study Locations (15)
Other
- Perth Children's Hospital - Nedlands
- Royal Children's Hospital - Parkville
- Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo - São Paulo
- Guangzhou women and children's medical center - Guangzhou
- Shanghai Children's Medical Center - Shanghai
- Shengjing Hospital of China Medical University - Shenyang
- West China Hospital and West China Second University Hospital - Sichuan
- Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants - Bordeaux
- Post Graduate Institute of Medical Education and Research - Chandigarh
- Christian Medical College Hospital - Vellore
- Great Ormond Street Hospital for Children - London
Texas
- Children's Medical Center Dallas - Dallas
- Children's Memorial Hermann Hospital - Houston
New York
- Children's Hospital at Montefiore/Albert Einstein College of Medicine - New York
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2022-08-12 |
| Est. Completion | 2027-12-31 |
What NCT05673499 shows while recruiting
NCT05673499 is an observational study that tracks outcomes without assigning an intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 310-participant average among 4 other Congenital Disorders trials with a reported enrollment target (190% higher).
The record links to 3 conditions, with Congenital Disorders appearing as the primary indexed condition, and to 1 intervention - of which NIRS/EEG monitoring is the first listed.
NCT05673499 lists 15 locations in 4 states (Other, Texas, New York).
Frequently Asked Questions
What is clinical trial NCT05673499 about?
NCT05673499 is a clinical study titled "International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery". The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1. The perioperative factors associated with occurrence of cerebral desaturation 2. The as...
What is the current status of trial NCT05673499?
This trial is currently recruiting. The enrollment target is 900 participants. The study started on 2022-08-12. Estimated completion is 2027-12-31.
What conditions does trial NCT05673499 study?
This clinical trial studies the following conditions: Congenital Disorders, Cerebral Desaturation, Neonatal Surgery.
What interventions are being tested in trial NCT05673499?
The interventions under investigation include: NIRS/EEG monitoring (DEVICE).
Who is sponsoring clinical trial NCT05673499?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05673499 being conducted?
This trial has 15 study locations across New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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