Needle Aspiration for Large Cephalohematoma

Completed

• Conditions: Cephalohematoma

• Registration Number: NCT03875456
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The cephalohematoma is a common pathology of newborns. Observation is the primary treatment for the most of small uncomplicated cephalohematoma. However large cephalohematoma can lead to calcification with anesthetic local deformation or deformational plagiocephaly. The objective of the study was to evaluate the iatrogenic risk associated with early puncture on local anesthesia.

Detailed Description

This is a retrospective study of 67 newborns followed at the University Hospital of Montpellier between 2010 and 2017. Treatment was puncture under local anesthesia between 2 and 4 weeks of life.

Any potential complication events were searched retrospectively during the month after the puncture. Analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in Pediatric Emergency department and finally read of the report of the clinical control 1 month after the procedure

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-02-01
• Status Verified: 2019-03
• Study Completion: 2019-03-01
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Study First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication events during the month after the puncture.	1 day	retrospective data collection. Analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in Pediatric Emergency department and finally read of the report of the clinical control 1 month after the procedure

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France