NCT02386228

Brief Summary

A collection of biological samples (cerebrospinal fluid \[CSF\] and blood) from patients under 6 years of age who are diagnosed with intraventricular hemorrhage or spina bifida.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

March 5, 2015

Last Update Submit

January 5, 2017

Conditions

Intraventricular HemorrhageSpina Bifida

Keywords

miRNAposthemorrhagic hydrocephalus (PHH)

Outcome Measures

Primary Outcomes (1)

  • miRNA sequences

    Identification of miRNA sequences common to patients with IVH and patients with spina bifida to determine condition specific expression profiles, multivariate analysis of candidate miRNA sequences that are differentially expressed between the two conditions but between different outcomes (development of hydrocephalus) to target potential markers. Once identified, mechanisms for the rapid detection of marker sequences will be developed and their predictive value tested in future collections.

    within 30 days of blood or CSF collection

Interventions

collection of CSF and bloodGENETIC

collection of CSF and blood

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

infants with IVH or spina bifida

You may qualify if:

  • Age between 0 and 6 years.
  • Diagnosis of IVH or spina bifida
  • Granted access to CSF and blood via surgery, CSF diversion device, venous access, and/or arterial access.

You may not qualify if:

  • Older than 6 years.
  • Diagnosis of infection or other acute inflammatory process involving the central nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

CSF and blood

MeSH Terms

Conditions

Spinal Dysraphism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Robert Spetzler, MD

    Barrow Brain and Spine physician with SJHMC privileges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Clinician

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

US(1)