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

Phase 2

• Conditions: Late-Onset Neonatal Sepsis; Pre-Term; Sepsis

• Registration Number: NCT04717037
• Lead Sponsor: King Abdullah International Medical Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-12-08
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-18
• Last Update Submitted: 2021-01-18
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of culture-proven sepsis in the blood or CSF	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.

Secondary Outcome Measures

Name	Time	Method
Neonatal Skin Condition score	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.

Trial Locations

Locations (2)

King Abdulaziz Medical City; 🇸🇦 Jeddah, WR, Saudi Arabia

King Abdulaziz University Hospital; 🇸🇦 Jeddah, Saudi Arabia