NCT04568538 is a NA clinical trial of Training program in Shaken Baby Syndrome, sponsored by Akdeniz University.

Who is sponsoring NCT04568538?

NCT04568538 is sponsored by Akdeniz University.

What drugs are being tested in NCT04568538?

Interventions in NCT04568538: Training program.

What condition does NCT04568538 study?

NCT04568538 studies Shaken Baby Syndrome, Mothers.

Is NCT04568538 still recruiting?

NCT04568538 is currently completed. Last updated 17 December 2021.

Last reviewed 2021-12-17 · How we verify

NCT04568538

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect of a Shaken Baby Syndrome Prevention Program

Completed NA Last updated 17 December 2021

What this trial tests

NA trial testing Training program in Shaken Baby Syndrome in 87 participants. Completed in 20 February 2021.

Timeline

20 January 2019

Primary endpoint
20 September 2020

20 February 2021

Quick facts

Lead sponsor	Akdeniz University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	87
Start date	20 January 2019
Primary completion	20 September 2020
Estimated completion	20 February 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

Training program

Conditions studied

Shaken Baby Syndrome — all drugs for Shaken Baby Syndrome →
Mothers — all drugs for Mothers →

Sponsor

Akdeniz University

Who can join

Adults 2 Months to 4 Months, any sex, with Shaken Baby Syndrome or Mothers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: This randomized controlled study aims to examine whether the education program prepared to prevent shaken baby syndrome has an effect on mothers' knowledge and attitudes. Method: Simple randomization will be used to evaluate the intervention and control groups. The study will be carried out with 90 mothers babies of 2-4 months, who applied to Akdeniz University Hospital Healthy Child Outpatient Clinic (intervention group: 45, control group: 45). After the pre-test, the mothers in the intervention group will be trained and a booklet will be given. Tele-consultancy service will be provided to mothers during the 2-month follow-up period. After 2 months of follow-up, a post-test will be applied to the mothers in the intervention group. The mothers in the control group will not be intervened after the pretest is applied. A post test will be applied 2 months after the pre-test. After the post-test, the mothers in the control group will be trained and a booklet will be given. Ethics committee approval and institutional permission were obtained for the study. Verbal and written consent will be obtained from the mothers during the data collection phase.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The effect of a shaken baby syndrome prevention program on Turkish mothers' awareness and knowledge: A randomized controlled study.
Kaya A, Çelik D, Efe E. · · 2022 · cited 4× · PMID 35118794 · DOI 10.1111/jspn.12369

Verify or expand the search:

Other trials of Training program

Trials testing the same drug.

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Other Akdeniz University trials

Trials by the same sponsor.

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NCT07507279 — Technology-based Hand Rehabilitation in Older People · NA · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04568538 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Akdeniz University
Last refreshed: 17 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04568538.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing