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

Sponsor

King Abdullah International Medical Research Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04717037

Collaborator

King Abdulaziz University (Other)

300

Enrollment

Locations

Arms

Anticipated Duration (Months)

150

Patients Per Site

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Pre-Term Late-Onset Neonatal Sepsis	Biological: Olive Oil Massage	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Weeks to 32 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Preterm infants born at one of the participated centers.
Preterm Infants born at ≥24weeks gestation and ≤32weeks gestation
Birth weight ≥ 500gm up to 2000 gm.

Exclusion Criteria:

Outborn Infants.
Preterm infants < 24wk or > 32 wk
Preterm infants < 500 gm or > 2000gm
Critically ill patients, e.g., Hemodynamic unstable, culture-confirmed neonatal sepsis, Hydrops fetalis, Life-threatening congenital anomalies.
Congenital skin anomalies or infection
Major surgical procedure
Any patient whose parents refuse consent.
Death within 48 hours of life.