Genetic Testing in Detection of Late-Onset Hearing Loss

NCT00511381 | Completed DMC

• 1 other identifier: PDX-001-07
• Study Type: observational
• Target: 3,681
• Locations: 1 country
• Sites: 3

Brief Summary

Two major limitations of existing audiometric newborn hearing screening programs are their inability to detect forms of deafness that are not expressed at birth and the low compliance with obtaining recommended audiologic confirmation and/or follow-up. Molecular genetic tests on blood spots from all newborns will identify those at risk for the most frequent causes of late-onset hearing loss and to add these infants to the group who should receive continued audiologic monitoring.

Conditions

Hearing Loss; Late-Onset Hearing Loss; Deafness

Keywords

Hearing Loss; Late-Onset Hearing Loss; Deafness

Interventions

No intervention GENETIC

No intervention

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospital

You may qualify if:

• Documentation of informed consent
• Inborn
• Ability to do ABR (auditory brainstem response screen technology) screening test on all participants
• Age at enrollment less than 14 days or less than or equal to 336 hours (Birth date is day 0)
• Gestational age \> = 34 0/7 weeks and above. (Late preterm infants and term infants)
• No major anomalies
• Ability to obtain blood sample prior to administration of any blood product transfusion
• Subjects' parents or legal guardian willing to provide follow-up data on their child. They will need to provide a telephone contact number and address for follow-up procedures

You may not qualify if:

• Older than 14 days of age or 336 hours
• Receipt of a blood product prior to the ability to obtain blood sample for genetic testing (SoundGene panel)
• Any major congenital anomalies. (chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia, or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)

Sponsors & Collaborators

• Pediatrix: lead

Study Sites (3)

Stormont-Vail HealthCare

Topeka, Kansas, 66604, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

MeSH Terms

Conditions

Hearing Loss; Deafness

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gail Lim, ARNP

  Pediatrix

  PRINCIPAL INVESTIGATOR

• Zhili Lin, MD, PhD

  Pediatrix Screening

  STUDY CHAIR

• Reese H Clark, MD

  Pediatrix

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2011
• Last Updated: March 1, 2012

Record last verified: 2012-02

Locations

US (3)