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The Kidney Hearing Study

Efficacy and Safety of Acoustic Stimuli as a Complementary Intervention for Acute Kidney Injury in a Double Blinded Parallel Multisite Randomized Controlled Trial in Nigerian Children: The Kidney Hearing Study (KIDHEAR Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202502549686475
Enrollment
35
Registered
2025-02-20
Start date
2024-04-24
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear, Nose and Throat Kidney Disease

Interventions

Running water sound therapy
Standard care for AKI

Sponsors

Michael Alao until sponsors are secured
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a. Nigerian children aged 2-18 years diagnosed with AKI. b. Stable haemodynamic status c. Willingness to participate in the study.

Exclusion criteria

Exclusion criteria: a. Children with history of pre-existing hearing impairments. b. Children with known neurologic or mental disorders c. Children with contraindications to auditory interventions such as abnormal pinnae, hyperacusis, acute or chronic ear infections, severe tinnitus, cognitive impairments, active psychosis d. Children who have received diuretics. e. Children with stage 3 AKI at presentation (may present with numerous confounding factors).

Design outcomes

Primary

MeasureTime frame
Urinary output in milliliters per kilogram per hour assessed post-intervention.

Secondary

MeasureTime frame
1. Renal function assessed using estimated glomerular filtration rate examined at 12-, 24-, 48-, and 72-hours’ post- randomization, as well as on the 7th day following the randomization. 2. Changes in fluid status of study participant form randomization to 72-hour post randomization. i. Daily weight changes ii. Percentage Fluid (over)load = [Daily fluid Intake(L)-Fluid output(L)/Baseline admission weight Kg] x 100 iii. Brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) 3. Adverse events related to auditory intervention.

Countries

Nigeria

Contacts

Public ContactMichael Alao

Hospital Consultant

michael.alao@uch-ibadan.org.ng2348167499548

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026