Measurement of anesthesia depth in asphyxated neonates during hypothermia treatment
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Severe acidosis (pH = 7.0 or BG = 16 mmol/L) from cord blood or a blood sample within the first hour of life and - Clinical signs of moderate or severe encephalopathy (grade 2 or 3 according to Sarnat & Sarnat) and - Postnatal age = 6 hours and - Gestational age = 36 weeks If no blood gas analysis is available, a decision can be made based on medical history: - Evidence of fetal hypoxia near birth (e.g., umbilical cord prolapse or rupture, uterine rupture, maternal trauma/hemorrhage, maternal cardiac arrest) and - APGAR score = 5 (after 10 minutes) or ventilation or resuscitation after birth for at least 10 minutes.
Exclusion criteria
Exclusion criteria: - Premature infants under 36+0 weeks of gestation - Contraindications for hypothermia therapy (acute bleeding, poor prognosis with a prenatally known underlying disease, etc.) - Patients in the study group who, contrary to the desired standard, did not receive anesthesia depth monitoring (e.g., due to unavailability of the appropriate equipment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative dose of opiates and sedatives administered during neonatal intensive care treatment which will be calculated retrospectively for the entire neonatal intensive care stay manually from archived patient charts. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to extubation after reaching Normothermia - Time to discharge from intensive care unit - Time to first enteral feed - Mortality - Prävalence and length of delirium | — |
Countries
Germany
Contacts
Klinikum Oldenburg