Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Early Phase 1 study, sponsored by Arizona State University.
NCT03838016 is a Early Phase 1 study that has completed, run by Arizona State University. The registered enrollment target is 285 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (438% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Standardized testing of speech sounds using a published test of articulation
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 |
What the finished NCT03838016 record still lists
NCT03838016 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (438% higher).
The record links to 0 conditions, and to 1 intervention - of which Babble Boot Camp is the first listed.
NCT03838016 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03838016's enrollment target sits among peer trials
285 40th of 2000 higher than 1,961 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03412877 · 285 participants · Phase 2
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
- NCT04537936 · 285 participants · NA
Psychotherapy Intervention for Latinos With Adv Cancer
- NCT04965675 · 285 participants · Phase 3
A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
- NCT05320835 · 285 participants · NA
A Setting Focus Overdose Prevention Intervention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI