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Control of anesthesia depth during hypothermia treatment after asphyxia

Control of anesthesia depth during hypothermia treatment after asphyxia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036731
Enrollment
73
Registered
2025-05-30
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Measurement of anesthesia depth in asphyxated neonates during hypothermia treatment

Interventions

Group 1: The intervention group consists of 32 neonates born between 2022 to 2024. They were transferred from partner hospitals of Klinikum Oldenburg after suffering asphyxia. They received hypothermi

Sponsors

Klinikum Oldenburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Days

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

MeasureTime 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

MeasureTime 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

Public ContactAxel Heep

Klinikum Oldenburg

kikra@klinikum-oldenburg.de0441 403-4255

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026