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NCT03838016 · ClinicalTrials.gov registry record · Early Phase 1
Preventing Speech and Language Disorders in Children With Classic Galactosemia
A Early Phase 1 study, sponsored by Arizona State University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 285
- Enrollment target
NCT03838016 is a Early Phase 1 study that has completed, run by Arizona State University. The registered enrollment target is 285 participants.
The verdict
NCT03838016, a Early Phase 1 study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 285 participants
- Enrollment target
Study Summary
A critical knowledge gap is whether proactive intervention can improve speech and language outcomes in infants at known risk for communication disorders. Speech and language assessments and treatments are usually not initiated until deficits can be diagnosed, no earlier than age 2-3 years. Preventive services are not available. Children with classic galactosemia (CG) hold the keys towards investigating whether proactive services are more effective than conventional management. CG is a recessively inherited inborn error of metabolism characterized by defective conversion of galactose. Despite early detection and strict adherence to lactose-restricted diets, children with CG are at very high risk not only for motor and learning disabilities but also for severe speech sound disorder and language impairment. Delays are evident from earliest signals of communication and persist into adulthood in many cases but speech/language assessment and treatment are usually not initiated until deficits manifest. However, because CG is diagnosed via newborn screening, the known genotype-phenotype association can be leveraged to investigate the efficacy of proactive interventions during the acquisition of prespeech (2 to 12 months) and early communication skills (13 to 24 months). If this proactive intervention is more effective than standard care regarding speech and language outcomes in children with CG, this will change their clinical management from deficit-based to proactive services. It will also motivate investigating this approach in infants with other types of known risk factors, e.g., various genetic causes and very low birth weight. The Babble Boot Camp is a program for children with CG, ages 2 to 24 months. The intervention is implemented by a pediatric speech-language pathologist (SLP) via parent training. Activities and routines are designed to foster earliest signals of communication, increase coo and babble behaviors, support the emergence of first words and word comb
Interventions
- BEHAVIORAL Babble Boot Camp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2025-08-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03838016
The ClinicalTrials.gov registry entry for NCT03838016 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 285 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Babble Boot Camp is the first listed.
NCT03838016 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03838016 about?
NCT03838016 is a clinical study titled "Preventing Speech and Language Disorders in Children With Classic Galactosemia". A critical knowledge gap is whether proactive intervention can improve speech and language outcomes in infants at known risk for communication disorders. Speech and language assessments and treatments are usually not initiated until deficits can be diagnosed, no earlier than age 2-3 years. Preventiv...
What is the current status of trial NCT03838016?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 285 participants. The study started on 2019-05-01. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT03838016?
The interventions under investigation include: Babble Boot Camp (BEHAVIORAL).
Who is sponsoring clinical trial NCT03838016?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
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