Neuroendoscopic lavage for treatment of intraventricular hemorrhage (IVH) and posthemorrhage hydrocephalus (PHH) among preterm infants

ISRCTN	ISRCTN86628725
DOI	https://doi.org/10.1186/ISRCTN86628725
Secondary identifying numbers	N/A

Submission date: 21/10/2015
Registration date: 30/11/2015
Last edited: 23/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Edward Ahn
Scientific

600 N. Wolfe Street
Phipps 560
Baltimore
21287
United States of America

Phone	+1 (0)410 502 7700
Email	eahn4@jhmi.edu

Study information

Study design	Single-center interventional study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Neuroendoscopic lavage for treatment of intraventricular hemorrhage (IVH) and posthemorrhage hydrocephalus (PHH) among preterm infants: a single-center interventional study
Study objectives	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(s)	Johns Hopkins Office of Human Subjects Research Institutional Review Board, 17/09/2015, Study Number IRB00065909
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2015
Completion date	01/11/2018

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	18
Key inclusion criteria	Premature infants with intraventricular hemorrhage (IVH) and posthemorrhagic hydrocephalus (PHH) who are eligible for a ventriculosubgaleal shunt or ventricular access device
Key exclusion criteria	Patients not suitable for surgical intervention in the operating room
Date of first enrolment	01/11/2015
Date of final enrolment	01/11/2018

Locations

Countries of recruitment

United States of America

Study participating centre

Johns Hopkins Hospital

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

Sponsor information

Johns Hopkins Hospital (USA)
Hospital/treatment centre

600 N. Wolfe Street
Baltimore
21287
United States of America

Phone	+1 (0)410 502 7700
Email	eahn4@jhmi.edu
"ROR"	https://ror.org/05cb1k848

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan