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OpenTrials
Completed

NCT Number: NCT03875456

Needle Aspiration for Large Cephalohematoma

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.

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Key information

Conditions

Cephalohematoma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Plagiocephaly

Age range

15 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Complication events during the month after the puncture.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Needle Aspiration for Large Cephalohematoma : a Retrospective Study of Complications

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 14, 2019
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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