NCT03875456

Completed

Needle Aspiration for Large Cephalohematoma

University Hospital, Montpellier Source

Other study identifiers

Sponsor study identifier

RECHMPL19_0107

Study Type

observational

Actual enrollment (reported)

67

Locations

1 country

Sites

1

Timeline

Study Start

December 1, 2018

Actual (reported)

Primary Completion

February 1, 2019

Actual (reported)

Study Completion

March 1, 2019

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 67 participants
Study completion date: March 1, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 1, 2018
Actual (reported)
Primary Completion
February 1, 2019
Actual (reported)
Study Completion
March 1, 2019
Actual (reported)
First Submitted
March 13, 2019
Actual (reported)
First Posted
March 14, 2019
Actual (reported)

Last Updated: March 14, 2019
Status Verified: March 2019
Last Update Submitted: March 13, 2019

Conditions

Cephalohematoma

Keywords

CephalohematomaInfant, NewbornPerinatal CarePlagiocephalyNonsynostoticSkull/pathology

Outcome Measures

Primary Outcomes (1)

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

Eligibility Criteria

Age15 Days - 30 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

patients presenting cephalohematoma

You may qualify if:

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

Sponsors & Collaborators

University Hospital, Montpellier
Otherlead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

MeSH Terms

Conditions

Plagiocephaly

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Guillaume CAPTIER, MD.PhD
University Hospital, Montpellier
STUDY DIRECTOR

Enrollment

67 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 14, 2019

Study Start

December 1, 2018

Actual (reported)

the diagnosis was confirmed by ultrasound examination

You may not qualify if:

Skull fracture (seen by ultrasound examination)
Intra-cranial complication (ultrasound examination)

Contact the study team to confirm eligibility.

Primary Completion

February 1, 2019

Actual (reported)

Study Completion

March 1, 2019

Actual (reported)

Last Updated

March 14, 2019

Record last verified: 2019-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03875456
Data provider: ClinicalTrials.gov
Source updated: 2019-03-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:46 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations