EUROMONITORING DURING SURGICAL REPAIR OFCONGENITAL DIAPHRAGMATIC HERNIA ANDESOPHAGEAL ATRESIA PATIENTS

Recruiting

Conditions: Surgical repair of Congenital Diaphragmatic Hernia or Esophageal Atresia

Registration Number: NL-OMON23869

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

Surgical repair of the diaphragmatic and esophageal defect should be performed after clinical
stabilization, defined as follows:

Exclusion Criteria

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The overall aim is to evaluate the association between cerebral oxygenation and activity as<br>evaluated perioperative by NIRS and aEEG and evaluation of growth and neurodevelopment<br>within the first two years of age.

Secondary Outcome Measures

Name	Time	Method
-Evaluation by NIRS and aEEG to compare open, minimal access surgery (MAS) and<br>conversion from MAS to open surgery of the diaphragm defect for 24 hours.<br /><br>- Transcutaneous CO2 measurements<br /><br>- Pre- and postoperative intensive care management:<br /><br>* Ventilation settings and need of oxygen<br /><br>* Use of vaso-active medication<br /><br>* (Postoperative) pain scores every eight hours (COMFORT scores)<br /><br>- Number of ventilator free days at day 28<br /><br>- Prenatal screening ultrasound results for CDH neonates<br /><br>- Length of stay (LOS)<br /><br>- Cranial ultrasound pre- and postoperative, at discharge from paediatric centre<br /><br>- Arterial blood gas analysis perioperative<br /><br>- Contralateral renal and quadriceps muscle tissue oxygenation starting 3 hours before<br>surgery till 24 hours postoperative<br /><br>- Recurrence rate in the two years after surgery<br /><br>- Neurodevelopmental outcome at 6, 12, 18 and 30 months