- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04717037
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS) (OMEPS)
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS), Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Jubara Alallah
- Phone Number: 28335 966554688775
- Email: AlallahJS@ngha.med.sa
Study Locations
-
-
-
Jeddah, Saudi Arabia
- Not yet recruiting
- King AbdulAziz University Hospital
-
Contact:
- Saad Alsaedi
-
-
WR
-
Jeddah, WR, Saudi Arabia, 21423
- Recruiting
- King Abdulaziz Medical City
-
Contact:
- Jubara Alallah, MD
- Phone Number: 22069 0122266666
- Email: alallahjs@ngha.med.sa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Preterm infants born at one of the participated centers.
- Preterm Infants born at ≥24weeks gestation and ≤32weeks gestation
- Birth weight ≥ 500gm up to 2000 gm.
Exclusion Criteria:
- Outborn Infants.
- Preterm infants < 24wk or > 32 wk
- Preterm infants < 500 gm or > 2000gm
- Critically ill patients, e.g., Hemodynamic unstable, culture-confirmed neonatal sepsis, Hydrops fetalis, Life-threatening congenital anomalies.
- Congenital skin anomalies or infection
- Major surgical procedure
- Any patient whose parents refuse consent.
- Death within 48 hours of life.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study
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 .
|
olive oil massage application.
|
No Intervention: Control
Patients who are assigned to the control group will receive standard care as per unit policies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of culture-proven sepsis in the blood or CSF
Time Frame: 72 hours from birth till 28 days of life
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal Skin Condition score
Time Frame: 72 hours from birth till 28 days of life
|
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. |
72 hours from birth till 28 days of life
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jubara Alallah, King Abdulaziz Medical city , WR
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJ20/109/J
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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