Perbandingan Nilai Apparent Diffusion Coefficient Pada Mielin Di Area White Matter Dan Morfologi Otak Menggunakan MRI Antara Anak Dengan Dan Tanpa Global Developmental Delay
Tahapan Penelitian : Recruit
Sponsor:
Individual
Mitra Pelaksana:
Prof Dr. IGNG Ngoerah Hospital, Department of Radiology, Faculty of Medicine Udayana University
No Registry
INA-5FCS7ORO
Tanggal Input Registry : 29-09-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 10-09-2025 |
| Outcome Primer | Children with major non-GDD structural brain abnormalities such as extensive cortical malformations |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Perbandingan Nilai Apparent Diffusion Coefficient Pada Mielin Di Area White Matter Dan Morfologi Otak Menggunakan MRI Antara Anak Dengan Dan Tanpa Global Developmental Delay |
| Judul Penelitian Ilmiah | Perbandingan Nilai Apparent Diffusion Coefficient Pada Mielin Di Area White Matter Dan Morfologi Otak Menggunakan MRI Antara Anak Dengan Dan Tanpa Global Developmental Delay |
| Jenis Penelitian | Observational |
| Intervensi | |
| Jumlah Subyek Penelitian | 38 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Children aged ≥2 years and ≤5 years who underwent brain MRI examination at Prof. Ngoerah General Hospital between January 2020 and July 2025.Exclusion Criteria: Children with major non-GDD structural brain abnormalities such as extensive cortical malformations, obstructive hydrocephalus, and encephalomalacia; those with a history of moderate to severe head trauma or central nervous system infection; children with confirmed genetic or metabolic syndromes showing abnormal myelination patterns; cases with significant MRI artifacts that interfere with ROI interpretation; children with ferromagnetic metal implants or medical devices incompatible with MRI; those with unstable medical conditions; and MRI scans of inadequate quality |
| Administrative Information | |
| Nomor Persetujuan Etik | 2194/UN14.2.2.VII.14/LT/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Crystina Ayu Putri |