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

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

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 Overview

• Status: Unknown
• Conditions: Sepsis; Pre-Term; Late-Onset Neonatal Sepsis
• Intervention / Treatment: Biological: Olive Oil Massage

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • 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: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

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 .	Biological: Olive Oil Massage; 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	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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Collaborators: King Abdulaziz University
• Investigators: Principal Investigator: Jubara Alallah, King Abdulaziz Medical city , WR

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Massage; Preterm; Olive oil; Late-Onset sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: RJ20/109/J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No