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NCT06930482
Evaluation of The Effectiveness of The SAFE Early Intervention Program
NA trial testing Safe early intervention in Preterm in 46 participants. Completed in 1 January 2023.
1 September 2021
Quick facts
| Lead sponsor | Gazi University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 January 2021 |
| Primary completion | 1 September 2021 |
| Estimated completion | 1 January 2023 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Safe early intervention
- early intervention approach based on neurodevelopmental treatment
Conditions studied
- Preterm — all drugs for Preterm →
- Sensory Disorders — all drugs for Sensory Disorders →
- Cerebral Palsy — all drugs for Cerebral Palsy →
Sponsor
Gazi University
Who can join
Adults 3 Months to 12 Months, any sex, with Preterm or Sensory Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Long-Term Neurodevelopmental Outcomes of the SAFE Early Intervention in Infants at Risk: A Randomised Controlled Trial.
Yildiz R, Yildiz A, Apaydin U, Efkere PA, et al · · 2025 · PMID 40891629 · DOI 10.1111/jpc.70191
Verify or expand the search:
- PubMed search for NCT06930482
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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)
- Trial protocol + status: ClinicalTrials.gov NCT06930482 (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 Gazi University
- Last refreshed: 16 April 2025
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/NCT06930482.
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