ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 30 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"
Previous Study | Return to List | Next Study

Improving Infant Hydrocephalus Outcomes in Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03650101
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
Penn State University
The Hospital for Sick Children
CURE Children's Hospital, Uganda
Information provided by (Responsible Party):
Pei-Yi Lin, Boston Children’s Hospital

Brief Summary:
Neonatal postinfectious hydrocephalus (PIH) is a major public health problem in East Africa.The standard treatment has long been placement of a ventriculoperitoneal shunt (VPS) but these devices require life-long maintenance and nearly all fail multiple times. Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC) is an alternate treatment to give patients a shunt-free life. In this study, the investigators aim to optimize the metrics of evaluation as quantitative prognostic indicators of treatment response and long term outcomes.

Condition or disease Intervention/treatment
Hydrocephalus Procedure: ETV/CPC

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Infant Hydrocephalus Outcomes in Uganda: Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure After ETV/CPC
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus


Intervention Details:
  • Procedure: ETV/CPC
    The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.


Primary Outcome Measures :
  1. Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score [ Time Frame: 24 months of age ]
    Scores on the BSID-3, which is used to evaluate infants and toddlers 1 to 42 months of age, range from 1 to 19, with higher scores indicating better performance; the mean (±standard deviation(SD)) score in the general population is 10±3.

  2. Incidence of ETV/CPC treatment failure [ Time Frame: 6 months post-treatment ]

    Treatment failure or success will be determined with the use of clinical and radiographic criteria.

    • Treatment success will be determined as the shift in the growth of head circumference to a normal rate, as plotted on a standard growth chart; decompression of the anterior fontanel; relief of symptoms of elevated intracranial pressure, such as irritability and vomiting; resolution of down-gaze or sixth cranial nerve palsy; and a decrease or arrest in ventriculomegaly as determined on Computerized Tomography (CT).
    • Treatment failure will be defined as treatment-related death or the need for a second operation for infection or for the recurrence of hydrocephalus.


Secondary Outcome Measures :
  1. Cerebral oxygen metabolism [ Time Frame: pre- and post-, 6, 12 months post-treatment and 24 months of age ]
    cerebral oxygen metabolism will be measured with near-infrared spectroscopy

  2. brain volume [ Time Frame: pre- and post-, 6, 12 months post-treatment and 24 months of age ]
    brain volume will be quantitatively estimated from the head CT scan

  3. Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score at 12 months post-treatment [ Time Frame: 12 months post-treatment ]
    Scores on the BSID-3, which is used to evaluate infants and toddlers 1 to 42 months of age, range from 1 to 19, with higher scores indicating better performance; the mean (±standard deviation) score in the general population is 10±3.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 180 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infants less than six months old with progressive hydrocephalus
Criteria

Inclusion Criteria:

  • Infants less than 180 days (six months) old
  • Symptomatic hydrocephalus
  • Post-infectious Hydrocephalus based on clinical and CT parameters
  • A parent or a guardian qualified by Ugandan law to give informed consent
  • Patients from one of 31 districts in eastern Uganda to ensure ready follow-up access will be eligible for the study

Exclusion Criteria:

  • Age greater than six months
  • No evidence of progressive hydrocephalus
  • Patients outside of the districts specified in the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650101


Contacts
Contact: Pei-Yi Lin, PhD 6179191308 Ivy.Lin@childrens.harvard.edu

Sponsors and Collaborators
Boston Children’s Hospital
Penn State University
The Hospital for Sick Children
CURE Children's Hospital, Uganda

Responsible Party: Pei-Yi Lin, Assistant Professor, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03650101     History of Changes
Other Study ID Numbers: P00029806
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with researchers outside of the study team.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pei-Yi Lin, Boston Children’s Hospital:
Hydrocephalus

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases