Postnatal head development of the preterm versus term infant head during the first year of life - a longitudinal observational study
- Conditions
- Q67.3Q67.2DolichocephalyPlagiocephaly
- Registration Number
- DRKS00022940
- Lead Sponsor
- Zentrum Zahn-, Mund- und Kieferheilkunde / Poliklinik für Kieferorthopädie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 51
preterm group:
preterm infants with a birth weight of < 1500 g and / or a gestational age of < 32+0 weeks
term group:
term infants, that don't meet any exclusion criteria
General exclusion criteria for study participation:
• Palliative care
General exclusion criteria for the control group:
- 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
Exclusion criteria for the single measurement for all patients:
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Establishing cephalometric standard parameters for head shape and volume in preterm infants from term equivalent age until the first corrected birthday
- Secondary Outcome Measures
Name Time Method Comparing cephalometric parameters for head shape and volume in preterm versus term infants during the first year of life