RECRUITING

CEUS Evaluation of Hydrocephalus in Neonates and Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Hydrocephalus affects up to 2 out of every 500 births and results in long-term disability in up to 78% of those affected. The standard treatment of hydrocephalus is cerebrospinal fluid (CSF) diversion via placement of an invasive ventricular shunt to relieve elevated intracranial pressure (ICP). The clinical decision for CSF diversion is based on the ventricular size and clinical symptoms which are not robust indicators of brain health in neonatal hydrocephalus. The purpose of this study is to assess the safety and feasibility of performing brain contrast-enhanced ultrasound (CEUS) in neonates and infants with diagnosed and/or suspected hydrocephalus.

Official Title

Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound

Quick Facts

Study Start:2025-02-15
Study Completion:2027-01-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06693752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Minute to 18 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Males and females younger than 1.5 years old with diagnosed and/or suspected hydrocephalus.
  2. 2. Post menstrual age of 26 weeks or older.
  3. 3. Inpatients at the Children's Hospital of Philadelphia.
  4. 4. Parental/Legally authorized representative permission.
  1. 1. Medical history of Lumason hypersensitivity.
  2. 2. Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team.
  3. 3. Respiratory instability as defined by rapid escalation of respiratory support in the past 12-24 hours (Increased fraction of inspired oxygen (FiO2) requirement and/or nitric oxide).

Contacts and Locations

Study Contact

Misun Hwang, MD
CONTACT
267-425-7110
hwangm@chop.edu
Santiago Martinez-Correa, MD
CONTACT
267-425-7139
martinezcs@chop.edu

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-15
Study Completion Date2027-01-21

Study Record Updates

Study Start Date2025-02-15
Study Completion Date2027-01-21

Terms related to this study

Keywords Provided by Researchers

  • Ultrasound
  • Contrast-enhanced ultrasound
  • Infant hydrocephalus

Additional Relevant MeSH Terms

  • Hydrocephalus in Infants
  • Hydrocephalus Acquired