Feasibility (signal quality =80% for =70% of the NeoDoppler measurement time) and composite outcome: death, IVH, ICH or PVL (assessed using ultrasound in the second week of life)
Conditions
Interventions
Group 1: In 60 preterm infants (gestational age 22+0 to 31+6 weeks), cerebral perfusion will be continuously monitored using NeoDoppler during the first 72 hours of life. Simultaneously, vital paramet
Sponsors
Universitätsklinikum Heidelberg - Klinik für Neonatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written consent of parents or legal guardians - Gestational age 22+0 to 31+6 weeks
Exclusion criteria
Exclusion criteria: - Clinical suspicion of a syndromic disorder or confirmed syndromic disorder - Congenital cardiac malformations (except Patent Ductus Arteriosus (PDA), Patent Foramen Ovale (PFO), small ventricular septal defect (VSD)) - Congenital cerebral malformations and vascular anomalies - Hydrops fetalis - Lack of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of cerebral perfusion (flow velocities, RI, PI), its changes over time during the transition period, with relevant short-term clinical outcome (composite outcome: death, IVH grades 2–3, ICH or PVL). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of death, IVH grade 1–3, ICH or PVL in the first two weeks of life. - Feasibility defined as time with signal quality over 80% for at least 70% during measuring time. - Association of changes in cerebral blood flow parameters (flow velocities, RI, PI) during blood sampling from central lines. - Association of changes in cerebral blood flow parameters (flow velocities, RI, PI) in patients with good response versus bad response to Indomethacin-therapy for PDA. Bad response is defined as the need of extending the Heidelberg standard therapy. - Association of changes in cerebral blood flow parameters (flow velocities, RI, PI) and clinical definitions of hypotension (as mean arterial pressure lower than 30 mmHg for at least 2 minutes). - Association between changes in cerebral blood flow parameters (flow velocities, RI, PI) and Vasoactive-Inotropic Score (VIS). - Assessment of interactions between cerebral perfusion parameters and vital signs as part of the evaluation of cerebral autoregulation in preterm infants. - Detection of Low-Frequency Oscillations (LFO) and association with birth parameters. - Association of CO2 levels and changes in cerebral perfusion parameters - Association between cerebral perfusion parameters and perfusion index (pulse oximetry) measured simultaneously at the right hand. | — |
Countries
Germany
Contacts
Public ContactSophia Trombello
Universitätsklinikum Heidelberg - Klinik für Neonatologie
Outcome results
None listed