Prospective analysis of the impact of structured telephone preparation on the efficiency of newborn hearing screening depending on socioeconomic factors

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040198

Enrollment

200

Registered

2026-06-16

Start date

2026-05-21

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Limited feasibility and efficiency of newborn hearing screening due to suboptimal examination conditions (e.g. awake or restless infant), which may lead to prolonged examination time or the need for repeat testing.

Interventions

Group 1: Standard care: Parents receive routine information during appointment scheduling (e.g. insurance card, referral, child health record). No structured preparation regarding the child’s sleep be

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants presenting for their first newborn hearing screening at the clinic and their legal guardians. Written informed consent from parents. Sufficient ability to communicate with the parents (with interpreter if necessary).

Exclusion criteria

Exclusion criteria: Severe underlying conditions of the infant (e.g. epilepsy as a contraindication for sleep deprivation, tracheostomy, active malignancy), acute infection on the day of examination, absence of a legal guardian able to provide consent, inability to communicate even with an interpreter, known familial hearing impairment with non-verbal communication, or technical issues preventing measurement.

Design outcomes

Primary

Measure	Time frame
WHAT: Successful completion of newborn hearing screening at the first appointment, defined as a fully evaluable measurement (OAE and AABR, supplemented by tympanometry if required) without interruption and without the need for immediate rescheduling. WHEN: Assessed on the day of examination during the initial appointment. HOW: Documented by the examiner using the standardized clinical measurement protocol.	—

Measure

Time frame

WHAT: Successful completion of newborn hearing screening at the first appointment, defined as a fully evaluable measurement (OAE and AABR, supplemented by tympanometry if required) without interruption and without the need for immediate rescheduling. WHEN: Assessed on the day of examination during the initial appointment. HOW: Documented by the examiner using the standardized clinical measurement protocol.

—

Secondary

Measure	Time frame
Screening duration, time to fall asleep, sleep behavior and sleep duration of the child, need for melatonin administration, influencing factors affecting the examination (e.g. technical issues, noise, parental non-compliance), implementation of preparation instructions by parents, functional health literacy (HLS19-Q12), socioeconomic status (Winkler Index), and subjective parental language proficiency. Data are collected on the day of examination and partly during the preparatory telephone call and via standardized questionnaires.	—

Measure

Time frame

Screening duration, time to fall asleep, sleep behavior and sleep duration of the child, need for melatonin administration, influencing factors affecting the examination (e.g. technical issues, noise, parental non-compliance), implementation of preparation instructions by parents, functional health literacy (HLS19-Q12), socioeconomic status (Winkler Index), and subjective parental language proficiency. Data are collected on the day of examination and partly during the preparatory telephone call and via standardized questionnaires.

—

Countries

Germany

Contacts

Public ContactKenan Dennis Sakmen

Universitätsklinikum Frankfurt

kenandennis.sakmen@unimedizin-ffm.de069630187750

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026