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

ConditionsCongenital DisordersCerebral DesaturationNeonatal Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 60
SponsorChildren's Hospital of Philadelphia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformat

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: Infants1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants with perioperative cerebral desaturation

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

Time frame
24 hours

Secondary outcomes

1

Isoelectric EEG

Determined by EEG amplitude ≤ 10mV for ≥ 2 secs

Time frame
up to 24 hours
2

Perioperative outcomes

Medical record review

Time frame
up to 100 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

Masimo Corporation

Collaborator

Source ClinicalTrials.gov
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