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

Sepsis Clinical Trial

— OMEPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717037
• Other study ID #: RJ20/109/J
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: January 2021
• Source: King Abdullah International Medical Research Center
• Contact: Jubara Alallah
• Phone: 966554688775
• Email: AlallahJS[@]ngha.med.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Late-Onset Neonatal Sepsis
• Neonatal Sepsis
• Pre-Term
• Sepsis
• Toxemia

Intervention

Biological:
• Olive Oil Massage
olive oil massage application.

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz Medical City	Jeddah	WR
Saudi Arabia	King Abdulaziz University Hospital	Jeddah

Sponsors (2)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center	King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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