Developmental Cochlear Nerve DeficiencyNCT01904448

Auditory Brainstem Implantation in Young Children

A study testing Auditory Brainstem Implantation in Children in people with Developmental Cochlear Nerve Deficiency and Acquired Cochlear Nerve Deficiency, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 months to 17 years
Conditions the study is for: Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency, Cochlear Aplasia
What is being tested?: Auditory Brainstem Implantation in Children
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: Sep 2012to 1 Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 months to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Pre-linguistic hearing loss (birth-5 yrs.; age at ABI 18 months-5yrs) with both:
MRI +/- CT evidence of one of the following: Cochlear nerve deficiency, Cochlear aplasia or severe hypoplasia, Severe inner ear malformation, Post-meningitis ossification
When a cochlea is present or patent, lack of significant benefit from CI despite consistent use (>6 mo.)
Post-linguistic hearing loss (<18 yrs. of age) with both:
Loss or lack of benefit from appropriate CI without the possibility for revision or contralateral implantation. Examples might include: Post-meningitis ossification, Bilateral temporal bone fractures with cochlear nerve avulsion, Failed revision CI without benefit
Previously developed open set speech perception and auditory-oral language skills

Show all 17Show fewer

No medical contraindications
Willing to receive the appropriate meningitis vaccinations
No or limited cognitive/developmental delays which would be expected to interfere with the child's ability to cooperate in testing and/or programming of the device, in developing speech and oral language, or which would make an implant and subsequent emphasis on aural/oral communication not in the child's best interest
Strong family support including language proficiency of the parent(s) in the child's primary mode of communication as well as written and spoken English.
Reasonable expectations from parents including a thorough understanding:
of potential benefits and limitations of ABI
of parental role in rehabilitation
that the child may not develop spoken language as a primary communication mode or even sufficient spoken language to make significant academic progress in an aural/oral environment
Involvement in an educational program that emphasizes development of auditory skills with or without the use of supplementary visual communication.
Able to comply with study requirements including travel to investigation sites.
Informed consent for the procedure from the child's parents/legal guardian.

Who cannot join

Pre- or post-linguistic child currently making significant progress with CI
MRI evidence of one of the following:
normal cochlea and cochlear nerves or NFII
brainstem or cortical anomaly that makes implantation unfeasible
Clear surgical reason for poor CI performance that can be remediated with revision CI or contralateral surgery rather than ABI.
Intractable seizures or progressive, deteriorating neurological disorder

Show all 14Show fewer

Unable to participate in behavioral testing and mapping with their CI. If this appears to be an age effect, ABI will be delayed until we can be assured that the child will be able to participate, as reliable objective measures of mapping are currently not available for mapping these devices.
Lack of potential for spoken language development. This will be considered the case when evidence of the following exist:
Severe psychomotor retardation, autism, cerebral palsy, or developmental delays beyond speech that would preclude usage of the device and oral educational development. Autism is a special case where there is the potential for delayed presentation. When early signs are considered present, our group routinely requests a comprehensive developmental assessment for further evaluation prior to considering routine evaluation. A specialized group is readily available at our institution for such an evaluation.
Unable to tolerate general anesthesia (cardiac, pulmonary, bleeding diathesis, etc.).
Need for brainstem irradiation
Unrealistic expectations on the part of the subject/family regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device.
Unwilling to sign the informed consent.
Unwilling to make necessary follow-up appointments.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600

Other trials in United States

About this study

Official title: An Early Feasibility Study of the Safety and Efficacy of the Nucleus 24 Auditory Brainstem Implant in Children With Cochlear or Cochlear Nerve Disorders Not Resulting From Neurofibromatosis Type II

To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or cochlear nerve disorders. These conditions can include: developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or cochlear malformation.

This study proposes to implant up to 10 young children (<5 yrs. of age) with the Nucleus 24 Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure, tolerance of device stimulation, and the potential for auditory benefit beyond that experienced with their CI. This study will provide the preliminary experience for a larger scale clinical trial.

Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development of sound awareness and improved speech understanding among children implanted with the ABI when compared to their baseline skills. Aim 3: Demonstrate the development of oral language skills following the use of the ABI that were not evident prior to its use.

Conditions: Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency, Cochlear Aplasia, Post-meningitis Cochlear Ossification, Cochlear Malformation
Being tested: Auditory Brainstem Implantation in Children
Keywords: pediatric, profound hearing loss, auditory brainstem implant, cochlear implant, developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitis cochlear ossification, cochlear malformation, CND

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Auditory Brainstem Implantation in ChildrenDevice

Study groups in NCT01904448
Study group	Role	What they receive
Auditory Brainstem Implant	Experimental	single-arm study of auditory brainstem implantation in children Receives: Device: Auditory Brainstem Implantation in Children

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of ABI Complications
Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid (CSF) leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.
Measured: Year 3

Secondary outcomes (18)

The Oral and Written Language Scales (OWLS) Listening Comprehension Score
OWLS-II: Listening Comprehension measures oral language reception, which is the understanding of spoken language. The examiner orally presents increasingly difficult words, phrases, and sentences to the participant and he/she responds by pointing to or stating which of four pictures is correct. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better listening comprehension. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.
Measured: Year 3
The Oral and Written Language Scales (OWLS) Oral Expression Score
OWLS-II: Oral Expression measures oral language expression, which is the use of spoken language. The examiner presents a verbal prompt along with a picture and the participant must respond orally to the prompt with increasingly difficult language. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better oral expression. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.
Measured: Year 3
Goldman-Fristoe Test of Articulation Scores (GFTA)
The GFTA-2 is a standardized, norm-based articulation measure that samples spontaneous sound production. Children are asked to respond to picture plates and verbal cues from the examiner with single words that test consonant accuracy in initial, medial, and final positions. This measure has norms based on the performance of normal-hearing children from age 2 years to 21 years.
Measured: Year 3
MacArthur-Bates Communicative Development Inventories (CDIs) Score
MacArthur-Bates Communicative Development Inventories (CDIs)
Measured: Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
This is a measure of the child's ability to vocalize on demand elicited by pictures of objects. Scores are derived from the percentage of time the child vocalized for 25 words.
Measured: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Measure of percent correct for use of syllables elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct number of syllables on 25 items.
Measured: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Measure of percent correct on initial consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced an initial consonant on 25 items.
Measured: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Measure of percent correct on vowel production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct vowel on 25 items.
Measured: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Measure of percent correct on consonant manner cues production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct manner of consonant production on 25 items.
Measured: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Measure of percent correct on final consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced a final consonant on 25 items.
Measured: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Measure of percent correct on consonant place cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct place of consonant production on 25 items.
Measured: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Measure of percent correct on consonant voicing cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct voicing of consonant production on 25 items.
Measured: Year 1, Year 2, Year 3
Change in Speech Perception Test Battery Scores-Detection Audiogram
Sound detection for octave frequencies of 250 Hz through 8k Hz were collected and a 4 frequency average was calculated for each annual test interval
Measured: Year 1, Year 2, Year 3
Speech Perception Test Battery Scores-IT-MAIS or MAIS
A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until demonstrating a minimum performance on the previous measure.
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) is a parent questionnaire consisting of ten questions regarding a young infant or toddler's auditory behavior, e.g., "Does the child spontaneously respond to his/her name in quiet with auditory cues?" Each question is scored on a five point scale: 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, and 4 = always. The aim of this tool is to assess the benefit of the child's personal amplification device(s) and is used to assess hearing aid benefit. Higher scores reflect more consistent auditory response. Scores reported are the percentage of correctly answered questions of the total asked.
Measured: Pre-ABI, Year 1, Year 2, Year 3
Change in Speech Perception Test Battery Scores-Ling Sound Test
A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure.
The Ling- 6 sounds test is a speech sound detection measurement of detection thresholds performed by an audiologist. Six sound files of "ah", "ee", "oo", "sh", "s", and "m" are presented one at a time in varying order for measurement of hearing threshold groups, per sound. The selected sounds tested validate hearing device fitting across the frequency range important for understanding speech. If the child can detect the stimuli a point is given and if they can not detect, no point is given. A total of 3 trials per sound were presented for a total of 18 presentations. The score reflects a percent of the total sounds that were detected.
Measured: Year 1, Year 2, Year 3
Change in Speech Perception Test Battery Scores-ESP Low Verbal
A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure.
The Early Speech Perception (ESP) low verbal version estimates speech perception abilities in very young children who have limited verbal abilities. Stimuli consist of words varying in pattern as well as spondees and monosyllabic words presented in sets of four. The format is four item closed-set. Test materials consist of objects (toys) instead of pictures. It is scored by the percent of correctly identified items from the set of 4; 3 repetitions of each item are given for a total of 12 trials.
Measured: Year 1, Year 2, Year 3
Change in Speech Perception Test Battery Scores-ESP Standard
A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure. This may have been due to child's age or inability to complete task. The Early Speech Perception (ESP) Standard measures the progression of speech discrimination skills in children (age 5+) with profound hearing loss as they develop. The stimuli consist of 3 subtests [1) patterns and words, 2) monosyllable, 3) spondees] of 12 pictured words each presented in an auditory-only condition. The format is a closed-set. Two repetitions of each item are given for a total of 24 items for each subtest. Each subtest is scored by the percent of correctly identified items from the set of pictured words.
Measured: Year 1, Year 2, Year 3
Pre-School Language Scale (PLS-5) Scores
The PLS-5 is a standardized language test designed for infants and young children. The Auditory Comprehension subscale targets skills known to precede language development, including: attention to speakers, appropriate object play, basic vocabulary, concepts, grammatical markers, and complex sentences. The Expressive Communication subscale assesses vocal development, social communication, naming of common objects, phonological awareness, sequencing skills, as well as use of concepts, prepositions, grammatical markers, and varying sentence structures.
Measured: Year 1, Year 2, Year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 20121 Oct 2017

First posted22 Jul 2013 (estimated)
Study startSep 2012
Primary completion1 Oct 2017
Study completion1 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Developmental Cochlear Nerve DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01904448
Sponsor's protocol ID: 12-0664
Status last verified: Feb 2018
First submitted: 3 Jul 2013
Last updated: 5 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Early Feasibility Study of the Safety and Efficacy of the Nucleus 24 Auditory Brainstem Implant in Children With Cochlear or Cochlear Nerve Disorders Not Resulting From Neurofibromatosis Type II
ClinicalTrials.gov ID: NCT01904448
Acronym / sponsor ID: 12-0664
Conditions: Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency, Cochlear Aplasia, Post-meningitis Cochlear Ossification, Cochlear Malformation
Keywords: pediatric, profound hearing loss, auditory brainstem implant, cochlear implant, developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitis cochlear ossification, cochlear malformation
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Study start: Sep 2012
Primary completion: 1 Oct 2017 (actual)
Study completion: 1 Oct 2017 (actual)
First posted: 22 Jul 2013 (estimated)
Results: Posted 6 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Auditory Brainstem Implant	Experimental	Device: Auditory Brainstem Implantation in Childrensingle-arm study of auditory brainstem implantation in children

Who may qualify

Ages: 18 months to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (17 listed)

Pre-linguistic hearing loss (birth-5 yrs.; age at ABI 18 months-5yrs) with both:
MRI +/- CT evidence of one of the following: Cochlear nerve deficiency, Cochlear aplasia or severe hypoplasia, Severe inner ear malformation, Post-meningitis ossification
When a cochlea is present or patent, lack of significant benefit from CI despite consistent use (>6 mo.)
Post-linguistic hearing loss (<18 yrs. of age) with both:
Loss or lack of benefit from appropriate CI without the possibility for revision or contralateral implantation. Examples might include: Post-meningitis ossification, Bilateral temporal bone fractures with cochlear nerve avulsion, Failed revision CI without benefit

Key exclusion criteria (14 listed)

Pre- or post-linguistic child currently making significant progress with CI
MRI evidence of one of the following:
Clear surgical reason for poor CI performance that can be remediated with revision CI or contralateral surgery rather than ABI.
Intractable seizures or progressive, deteriorating neurological disorder
Unable to participate in behavioral testing and mapping with their CI. If this appears to be an age effect, ABI will be delayed until we can be assured that the child will be able to participate, as reliable objective measures of mapping are currently not available for mapping these devices.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Auditory Brainstem Implantation in Children	Device	Auditory Brainstem Implant

Primary outcome

Number of ABI Complications
Time frame: Year 3
Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid (CSF) leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.

18 secondary outcomes

The Oral and Written Language Scales (OWLS) Listening Comprehension Score
Time frame: Year 3
The Oral and Written Language Scales (OWLS) Oral Expression Score
Time frame: Year 3
Goldman-Fristoe Test of Articulation Scores (GFTA)
Time frame: Year 3
MacArthur-Bates Communicative Development Inventories (CDIs) Score
Time frame: Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Time frame: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Time frame: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Time frame: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Time frame: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Time frame: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Time frame: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Time frame: Year 1, Year 2, Year 3
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Time frame: Year 1, Year 2, Year 3
Change in Speech Perception Test Battery Scores-Detection Audiogram
Time frame: Year 1, Year 2, Year 3
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Time frame: Pre-ABI, Year 1, Year 2, Year 3
Change in Speech Perception Test Battery Scores-Ling Sound Test
Time frame: Year 1, Year 2, Year 3
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Time frame: Year 1, Year 2, Year 3
Change in Speech Perception Test Battery Scores-ESP Standard
Time frame: Year 1, Year 2, Year 3
Pre-School Language Scale (PLS-5) Scores
Time frame: Year 1, Year 2, Year 3

Results and safety

Results posted to the registry on 6 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pediatric Auditory Brainstem Implantation (ABI)	5	5

Primary outcome: Number of ABI Complications

Time frame: Year 3. Number. Unit: Events

Measure	Pediatric ABI n = 5
Value	2

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the three year study course following enrollment for each participant.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pediatric ABI	2 of 5 (40%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): This study included only 5 participants and statistically reliable results were not possible. There was a floor effect for measures chosen to demonstrate device efficacy; they were found to be unspecific and insensitive to change observed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Craig A Buchman, MD study chair

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of ABI Complications (time frame: Year 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01904448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.