Needle Aspiration for Large Cephalohematoma

NCT ID: NCT03875456

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-03-01

Brief Summary

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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

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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

Conditions

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Cephalohematoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

15 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume CAPTIER, MD.PhD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL19_0107

Identifier Type: -

Identifier Source: org_study_id

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