Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| King Abdulaziz University | OTHER |
Not provided
Not provided
Not provided
Not provided
The OMEPS trial is a randomized clinical trial in the western region of Saudi Arabia. Conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of Late-Onset sepsis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Experimental | The olive oil massage will be applied initially at 72 hrs of life then twice daily with a dose of 4ml/kg till 28 days . |
|
| Control | No Intervention | Patients who are assigned to the control group will receive standard care as per unit policies. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olive Oil Massage | Biological | olive oil massage application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of culture-proven sepsis in the blood or CSF | Primary outcomes defined as the rate of culture-proven sepsis in the blood or CSF in the 28 days of life.Late-onset sepsis defined as sepsis onset after 72 h of life. The olive oil will be applied initially at 72 hours of life then twice daily with a dose of 4ml/kg. | 72 hours from birth till 28 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Skin Condition score | Validated Scoring system [ Neonatal Skin Condition Score ] will be used to score the skin integrity, and care will be monitored at baseline then weekly till age 28th of life or discharge. Skin condition was assessed with the Neonatal Skin Condition Score,This score has 9 scores from 1 to 9, 1 depicting the best skin state and 9 the worst with erythema, blistering & oozing over the entire area. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jubara Alallah | Contact | 966554688775 | 28335 | AlallahJS@ngha.med.sa |
| Name | Affiliation | Role |
|---|---|---|
| Jubara Alallah | King Abdulaziz Medical city , WR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical City | Recruiting | Jeddah | WR | 21423 | Saudi Arabia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D047928 | Premature Birth |
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 72 hours from birth till 28 days of life |
| King Abdulaziz University Hospital | Not yet recruiting | Jeddah | Saudi Arabia |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |