Postnatal head development of the infant head during the first year of life - a longitudinal observational study

• Conditions: Q67.3; Plagiocephaly

• Registration Number: DRKS00022558
• Lead Sponsor: niversitätsmedizin Göttingen, Abteilung für Pädiatrische Kardiologie und Intensivmedizin mit Neonatologie und Pneumologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-28
• Study Completion: 2021-09-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

parental consent
- Gestational age 37-42 weeks
- no relevant underlying disease

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

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 term infants from birth until the first birthday