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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04717037
Other study ID # RJ20/109/J
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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