Condition category
Circulatory System
Date applied
21/10/2015
Date assigned
30/11/2015
Last edited
23/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Posthemorrhagic hydrocephalus (PHH) is a build-up of fluid on the brain that occurs after bleeding inside the skull. The excess fluid puts pressure on the brain, which can damage it. PHH is a major problem for premature infants. Currently, most premature infants with this condition require a permanent ventriculoperitoneal (VP) shunt - a medical device that relieves the pressure on the brain. However, there is some evidence that washing away the blood with use of a long, thin, flexible tube called an endoscope will reduce the need for a shunt by resolving the build-up of fluid in the brain. The aim of this study is to find out whether washing away the blood with an endoscope reduces the need for a permanent VP shunt in premature infants with PHH.

Who can participate?
Premature infants with PHH who are eligible for a surgically implanted temporary device for draining excess cerebrospinal (brain) fluid.

What does the study involve?
All participants receive the same treatment. Eligible infants who are receiving a temporary shunt or device undergo a procedure to wash away the blood through an endoscope.

What are the possible benefits and risks of participating?
The benefit of this procedure is the possible reduction in the need for a permanent shunt. There is evidence that washing away the blood can resolve the build-up of fluid in the brain. Endoscopy at this young age can potentially increase the risk of seizures. Therefore, infants will be placed on temporary anti-seizure medications to reduce that risk.

Where is the study run from?
Bloomberg Children’s Center at the Johns Hopkins Hospital (USA)

When is the study starting and how long is it expected to run for?
November 2015 to November 2018

Who is the main contact?
Dr Edward Ahn
eahn4@jhmi.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Edward Ahn

ORCID ID

Contact details

600 N. Wolfe Street
Phipps 560
Baltimore
21287
United States of America
+1 (0)410 502 7700
eahn4@jhmi.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Neuroendoscopic lavage for treatment of intraventricular hemorrhage (IVH) and posthemorrhage hydrocephalus (PHH) among preterm infants: a single-center interventional study

Acronym

Study hypothesis

Adding an endoscopic lavage to ventriculosubgaleal shunt or ventricular access device insertion reduces the rate of requiring a permanent ventriculoperitoneal shunt in premature infants with intraventricular hemorrhage and post-hemorrhagic hydrocephalus.

Ethics approval

Johns Hopkins Office of Human Subjects Research Institutional Review Board, 17/09/2015, Study Number IRB00065909

Study design

Single-center interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intraventricular hemorrhage (IVH) and posthemorrhagic hydrocephalus (PHH)

Intervention

There is only one treatment arm in this study. With parental consent, eligible infants who are receiving a temporary ventriculosubgaleal shunt or ventricular access device will also receive the endoscopic lavage procedure. The endoscopic lavage procedure will use the same access point as the ventriculosubgaleal shunt. Bloody CSF will be irrigated and proteinaceous fluids removed from the ventricles. At the end of the lavage, we will insert the ventriculosubgaleal shunt per standard routine.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Rate of ventriculoperitoneal (VP) shunt insertion within 12 months of follow-up

Secondary outcome measures

1. Number of overall procedures
2. Rate of infection
3. Rate of supratentorial multiloculated hydrocephalus
Outcomes assessed at one year after the procedure

Overall trial start date

01/11/2015

Overall trial end date

01/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Premature infants with intraventricular hemorrhage (IVH) and posthemorrhagic hydrocephalus (PHH) who are eligible for a ventriculosubgaleal shunt or ventricular access device

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

18

Participant exclusion criteria

Patients not suitable for surgical intervention in the operating room

Recruitment start date

01/11/2015

Recruitment end date

01/11/2018

Locations

Countries of recruitment

United States of America

Trial participating centre

Johns Hopkins Hospital
600 N. Wolfe St Phipps 560
Baltimore
21287
United States of America

Sponsor information

Organisation

Johns Hopkins Hospital (USA)

Sponsor details

600 N. Wolfe Street
Baltimore
21287
United States of America
+1 (0)410 502 7700
eahn4@jhmi.edu

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes