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

King Abdullah International Medical Research Center300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Sepsis Pre-Term Late-Onset Neonatal Sepsis

Interventions

Olive Oil MassageBIOLOGICAL

olive oil massage application.

Eligibility

Sex: ALLMin age: 24 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: 1. Preterm infants born at one of the participated centers. 2. Preterm Infants born at ≥24weeks gestation and ≤32weeks gestation 3. Birth weight ≥ 500gm up to 2000 gm. Exclusion Criteria: 1. Outborn Infants. 2. Preterm infants \< 24wk or \> 32 wk 3. Preterm infants \< 500 gm or \> 2000gm 4. Critically ill patients, e.g., Hemodynamic unstable, culture-confirmed neonatal sepsis, Hydrops fetalis, Life-threatening congenital anomalies. 5. Congenital skin anomalies or infection 6. Major surgical procedure 7. Any patient whose parents refuse consent. 8. Death within 48 hours of life.

Locations (2)

King Abdulaziz Medical City

Jeddah, WR, Saudi Arabia

RECRUITING

King Abdulaziz University Hospital

Jeddah, Saudi Arabia

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 72 hours from birth till 28 days of life

Secondary Outcomes

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.

Time frame: 72 hours from birth till 28 days of life

Central Contacts

Jubara Alallah

CONTACT

966554688775 AlallahJS@ngha.med.sa

Data from ClinicalTrials.gov

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