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

Last updated: April 15, 2025
Sponsor: Children's Hospital of Philadelphia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

NIRS/EEG monitoring

Clinical Study ID

NCT05673499
22-019679
  • Ages < 60
  • All Genders

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.

Eligibility Criteria

Inclusion

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), congenitalcystic 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 proceduresthat meet the above criteria. These subjects will be counted more than once towardsthe enrollment goal.

  4. Parental/guardian permission.

Exclusion

Exclusion Criteria:

  1. Patients with hydrocephalus limiting frontal-parietal brain volume, interventricularhemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietalbrain.

Study Design

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: NIRS/EEG monitoring
Phase:
Study Start date:
August 12, 2022
Estimated Completion Date:
December 31, 2027

Study Description

The NIRS EEG sensors will be placed about an hour before surgery. The recording will start once sensors are placed, continue throughout the duration of surgery, and end 8-24 hours after end of surgery. Sensors will be removed at the end of recording. No additional anesthesia and/or sedation will be required for the preoperative and postoperative recordings. The EEG and NIRS monitors will be blinded to clinical staff. EEG and NIRS monitoring will not prolong anesthesia or the duration of the surgical repair, and should not interfere with routine patient care. NIRS and EEG data will be downloaded from the monitors at the end of recording for analysis.

Medical record review will be conducted at 100 days postop or hospital discharge (whichever is sooner). The information below will be extracted:

  • Respiratory record

  • Post-op recovery, ICU, and discharge records

  • Cardiac and Neurologic records

  • Neurologic test such as radiology and lab tests

  • Mortality status

Connect with a study center

  • Perth Children's Hospital

    Nedlands,
    Australia

    Active - Recruiting

  • Royal Children's Hospital

    Parkville,
    Australia

    Site Not Available

  • Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo

    São Paulo,
    Brazil

    Active - Recruiting

  • Guangzhou women and children's medical center

    Guangzhou,
    China

    Site Not Available

  • Shanghai Children's Medical Center

    Shanghai,
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang,
    China

    Site Not Available

  • West China Hospital and West China Second University Hospital

    Sichuan,
    China

    Site Not Available

  • Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants

    Bordeaux,
    France

    Site Not Available

  • Post Graduate Institute of Medical Education and Research

    Chandigarh,
    India

    Site Not Available

  • Christian Medical College Hospital

    Vellore,
    India

    Site Not Available

  • Great Ormond Street Hospital for Children

    London,
    United Kingdom

    Site Not Available

  • Children's Hospital at Montefiore

    New York, New York 10467
    United States

    Site Not Available

  • Children's Hospital at Montefiore/Albert Einstein College of Medicine

    New York, New York 10467
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Children's Medical Center Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

  • Children's Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

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