Needle Aspiration for Large Cephalohematoma

Cephalohematoma Clinical Trial

Official title:

Needle Aspiration for Large Cephalohematoma : a Retrospective Study of Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875456
• Other study ID #: RECHMPL19_0107
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion criteria:

• diagnosis of cephalohematoma was performed by the two senior plastic pediatric surgeon of the study

• the diagnosis was confirmed by ultrasound examination

Exclusion criteria:

• Skull fracture (seen by ultrasound examination)

• Intra-cranial complication (ultrasound examination)

Related Conditions & MeSH terms

• Cephalohematoma

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication events during the month after the puncture.	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	1 day