A Study to Establish a Registry for Treatment of Post-hemorrhagic Hydrocephalus in Neonates

Overview

About this study

The purpose of this study is to establish a prospective, standardized data collection for the patients who undergo surgical treatment of progressive post-hemorrhagic hydrocephalus in neonates with the focus on comparing neuroendoscopic lavage (NEL) with other standard treatment options such as external ventricular drainage (EVD), ventricular access device (VAD) and ventricular subgaleal shunt (VSGS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

 

  • No previous surgical treatment for hydrocephalus (HC).
  • Gestational age < 41 weeks at 1st neurosurgical  intervention.
  • IVH documented by US.
  • Hydrocephalus with progressing ventricular size (US ventricular indices above 97th percentile) diagnosed by pre-operative ultrasonography.
  • The ultrasonography represents the standard screening method and is obligatory to make the diagnosis. The following standard ventricular parameters should be gathered: bilateral Ventricular Index (VI); bilateral Anterior Horn Width (AHW); third Ventricle Width (TVW); bilateral Thalamo-Occipital Distance (TOD).
  • Surgically treated with any of the following: NEL, EVD, VAD, VSGS.
  • Ability to follow-up 5 years after initial surgical treatment.

Exclusion Criteria:

  • Comorbidity related instability forbidding surgical intervention.
  • Diagnosed impaired hemostasis in most recent laboratory results within up to 5 days before surgery (platelet counts < 50000/ml; prothrombin time (Quick) > 20 sec.; PTT > 50 sec.).
  • Proven CNS tumor.
  • Proven vascular malformation.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Edward Ahn, M.D.

Open for enrollment

Contact information:

Adam Loudermilk

(507)422-0718

Loudermilk.Adam@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available