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

Neuromonitoring during surgical repair of congenital diaphragmatic hernia and esophageal atresia patients - The NeMo CDH/EA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49066

Enrollment

Registered

2017-07-31

Start date

2017-08-21

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth defect of the diaphragm. hole in the diaphragm esophageal birth defect

Interventions

None listed

Eligibility

Age

No minimum to 11 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
* Evaluation by NIRS, aEEG, Zonare Doppler ultrasound and Cytocam-IDF to compare open, minimal access surgery (MAS) and conversion from MAS to open surgery of the diaphragm defect for 24 hours. * Transcutaneous CO2 measurements * Mitochondrial saturation * Pre- and postoperative intensive care management: * Ventilation settings and need of oxygen * Use of vaso-active medication * (Postoperative) pain scores every eight hours (COMFORT scores) * Number of ventilator free days at day 28 * Length of stay (LOS) * Prenatal screening ultrasound results for CDH neonates * Cranial ultrasound pre- and postoperative, at discharge from paediatric centre * Arterial blood gas analysis perioperative * Contralateral renal and quadriceps muscle tissue oxygenation starting 3 hours before surgery till 24 hours postoperative * Recurrence rate in the two years after surgery * Neurodevelopmental outcome at 6, 12, 18 and 30 months of age Page 9, 13,14,15	—

Measure

Time frame

* Evaluation by NIRS, aEEG, Zonare Doppler ultrasound and Cytocam-IDF to compare open, minimal access surgery (MAS) and conversion from MAS to open surgery of the diaphragm defect for 24 hours. * Transcutaneous CO2 measurements * Mitochondrial saturation * Pre- and postoperative intensive care management: * Ventilation settings and need of oxygen * Use of vaso-active medication * (Postoperative) pain scores every eight hours (COMFORT scores) * Number of ventilator free days at day 28 * Length of stay (LOS) * Prenatal screening ultrasound results for CDH neonates * Cranial ultrasound pre- and postoperative, at discharge from paediatric centre * Arterial blood gas analysis perioperative * Contralateral renal and quadriceps muscle tissue oxygenation starting 3 hours before surgery till 24 hours postoperative * Recurrence rate in the two years after surgery * Neurodevelopmental outcome at 6, 12, 18 and 30 months of age Page 9, 13,14,15

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Countries

Netherlands

Outcome results