Trial · NCT03875339
Communities Helping the Hearing of Infants by Reaching Parents
NCT03875339, Not applicable, Completed, Matthew Bush, MD; results first posted 2025-02-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Communities Helping the Hearing of Infants by Reaching Parents. Trials, record NCT03875339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03875339
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Communities Helping the Hearing of Infants by Reaching Parents
- NCT number
- NCT03875339
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,699 participants, actual
- Lead sponsor
- Matthew Bush, MD
- Conditions
- Congenital Hearing Loss
- Interventions
- Navigator Guidance
- First posted
- 2019-03-14
- Last updated
- 2025-02-14
- Results first posted
- 2025-02-14
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.) | This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | Navigator Arm | 378 | Participants | ||
| Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | Non-Intervention Arm | 336 | Participants |
Source ClinicalTrials.gov
Participant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Usual Care | STARTED | Wave 1: Usual Care Months 1-6, Intervention Month 7 Onward | 452 | 1 |
| Usual Care | STARTED | Wave 2: Usual Care Months 1-20, Intervention Month 21 Onward | 278 | 2 |
| Usual Care | STARTED | Wave 3: Usual Care Months 1-25, Intervention Month 26 Onward | 235 | 2 |
| Usual Care | STARTED | Wave 4: Usual Care Months 1-31, Intervention Month 32 Onward | 31 | 2 |
| Usual Care | STARTED | Wave 5: Usual Care Months 1-32, Intervention Month 33 Onward | 45 | 1 |
| Usual Care | STARTED | Wave 6: Usual Care Months 1-37, Intervention Month 38 Onward | 31 | 1 |
| Usual Care | STARTED | Wave 7: Usual Care Months 1-44, Intervention Month 45 | 26 | 1 |
| Usual Care | COMPLETED | Wave 1: Usual Care Months 1-6, Intervention Month 7 Onward | 452 | 1 |
| Usual Care | COMPLETED | Wave 2: Usual Care Months 1-20, Intervention Month 21 Onward | 278 | 2 |
| Usual Care | COMPLETED | Wave 3: Usual Care Months 1-25, Intervention Month 26 Onward | 235 | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Navigator Arm | 0 | 1,601 |
| Total, all-cause mortality | Non-Intervention Arm | 0 | 1,098 |
| Total, other adverse events | Navigator Arm | 0 | 1,601 |
| Total, other adverse events | Non-Intervention Arm | 0 | 1,098 |
| Total, serious adverse events | Navigator Arm | 0 | 1,601 |
| Total, serious adverse events | Non-Intervention Arm | 0 | 1,098 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35440449 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DC017770 | Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial | BUSH, MATTHEW LEE | UNIVERSITY OF KENTUCKY | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Navigator Arm vs Non-Intervention Arm: Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | Trial comparisons |
| Navigator Arm vs Non-Intervention Arm: deaths from any cause | Trial comparisons |
| Navigator Arm vs Non-Intervention Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03875339
GET https://conductscience.org/api/trials/v1/NCT03875339/flow?page=2