Q67.3
Conditions
Interventions
Group 1: In healthy newborns, that meet the inclusion criteria, five assessments of the head are performed using stereophotogrammetry to facilitate 3D reconstruction. The first assessment takes place
Sponsors
Universitätsmedizin Göttingen, Abteilung für Pädiatrische Kardiologie und Intensivmedizin mit Neonatologie und Pneumologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - parental consent - Gestational age 37-42 weeks - no relevant underlying disease
Exclusion criteria
Exclusion criteria: General: - Syndromal disease - extensive head deformities - Hydrocephalus - Intraventricular hemorrhage - Premature craniosynostosis of any kind - Neurological or muscular disorder - 5-minute-APGAR <7 - Development of a plagio- oder brachiocephalus during the study - gestational age < 37 weeks - Palliative care For the single measurement: - critical/deteriorating cllinical condition (i.e. severe sepsis, ECMO, PFC) Criteria for study drop out of a single patient: • clinical deterioration without improvement • disclaim of parental consent Criteria for termination of the study: • if there is evicence for risk to patient safety • if the study hypothesis is alreday answered after interim analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establishing cephalometric standard parameters for head shape and volume in term infants from birth until the first birthday | — |
Countries
Germany
Contacts
Public ContactJana Dieks
Universitätsmedizin Göttingen, Abteilung für Pädiatrische Kardiologie und Intensivmedizin mit Neonatologie und Pneumologie
Outcome results
None listed