Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)

Study Overview
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Brief Summary
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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.

Official Title
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Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS), Randomized Controlled Trial

Conditions
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Sepsis, Pre-Term, Late-Onset Neonatal Sepsis

Intervention / Treatment
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* Biological: Olive Oil Massage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br>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 . | Biological: Olive Oil Massage<br>* olive oil massage application.<br>|
| No Intervention: Control<br>Patients who are assigned to the control group will receive standard care as per unit policies. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 72 hours from birth till 28 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olive oil, Massage, Preterm, Late-Onset sepsis