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RECRUITING

International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

NCT05673499 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 900 participants
Start Date 2022-08-12
Est. Completion 2027-12-31

Sponsor

Children's Hospital of Philadelphia

492 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05673499

The ClinicalTrials.gov registry entry for NCT05673499 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 492 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05673499 reports 15 study locations spanning 4 distinct geographic areas — top geographies include Other, Texas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05673499?

The interventions under investigation include: NIRS/EEG monitoring (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05673499?

This trial is sponsored by Children's Hospital of Philadelphia, which has 492 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial