Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding.
Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values.
Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olive oil group | Active Comparator | Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra virgin organic olive oil (ULTRA PREMIUM) | Dietary Supplement | Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who completed the study | To enrolment of 40 babies in the study in both groups | 15 months |
| Postnatal growth retardation rates | Daily weight intake amounts of babies in both groups | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of retinopathy of prematurity | Frequency and severity of retinopathy of prematurity | 18 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayten ErdoÄŸan Ordu, MD | Contact | +905389429336 | aytenli21@hotmail.com | |
| Murat Tutanc, Prof | Contact | +905553803484 | drtutanc@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa City Hospital | Recruiting | Bursa | 16110 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41897040 | Derived | Dorum BA, Erdogan A, Cakir SC, Yarci E, Ozgur T, Unalli Ozmen S, Tutanc M. The Effect of Enteral Organic Extra Virgin Oil Supplementation in Premature Babies on Postnatal Growth, Premature Morbidities, and Oxidative Status. Children (Basel). 2026 Feb 26;13(3):327. doi: 10.3390/children13030327. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 17, 2026 | |
| Reset | Feb 4, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 17, 2026 | Feb 4, 2026 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |