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NCT Number: NCT05673499

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 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.

Recruiting

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Key information

Age range

Up to 60 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Perth Children's Hospital, Nedlands, Australia

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants ≤ 60 weeks post-menstrual age on day of surgery.
  • 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).
  • 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.
  • Parental/guardian permission.

Exclusion criteria

  • Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.

Treatment and study plan

NIRS/EEG monitoring

Device

The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.

Primary outcomes

  1. Percentage of participants with perioperative cerebral desaturation

    Time frame: 24 hours

    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

Secondary outcomes

  1. Isoelectric EEG

    Time frame: up to 24 hours

    Determined by EEG amplitude ≤ 10mV for ≥ 2 secs

  2. Perioperative outcomes

    Time frame: up to 100 days

    Medical record review

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Ramsay

CONTACT

[email protected]

267-270-5087

Paula Hu, RN, MSPH

CONTACT

[email protected]

267-426-2961

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Masimo Corporation

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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