euromonitoring during surgical repair of congenital diaphragmatic hernia and esophageal atresia patients

Recruiting

• Conditions: Birth defect of the diaphragm. hole in the diaphragm; 10018018; esophageal birth defect; 10017998

• Registration Number: NL-OMON49066
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

Surgical repair should be performed after clinical stabilization, defined as
follows:
* Mean arterial blood pressure normal for gestation.
* Preductal saturation levels of 85-95% on FiO2 below 50%
* Lactate below 3 mmol/l
* Urine output more than 1 ml/kg/h
Repair can be performed while the patient is on ECMO

Exclusion Criteria

Associated major cardiac anomalies/chromosomal anomalies or syndromes with
major cognitive impairment excluding surgical repair of the
diaphragmatic/esophageal defect due to futility.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The overall aim is to evaluate the association between cerebral oxygenation,<br /><br>activity and perfusion as evaluated perioperative by NIRS, aEEG, Zonare Doppler<br /><br>Ultrasound and Cytocam-IDF and evaluation of growth and neurodevelopment within<br /><br>the first two years of age.<br /><br><br /><br>Page 9, 13</p><br>