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

Primary Purpose

Sepsis, Pre-Term, Late-Onset Neonatal Sepsis

Status
Unknown status
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Olive Oil Massage
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sepsis focused on measuring Olive oil, Massage, Preterm, Late-Onset sepsis

Eligibility Criteria

24 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Abdulaziz Medical CityRecruiting
  • King Abdulaziz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study

Control

Arm Description

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 .

Patients who are assigned to the control group will receive standard care as per unit policies.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 8, 2020
Last Updated
January 18, 2021
Sponsor
King Abdullah International Medical Research Center
Collaborators
King Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT04717037
Brief Title
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)
Acronym
OMEPS
Official Title
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS), Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center
Collaborators
King Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Pre-Term, Late-Onset Neonatal Sepsis
Keywords
Olive oil, Massage, Preterm, Late-Onset sepsis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study
Arm Type
Experimental
Arm Description
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 .
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients who are assigned to the control group will receive standard care as per unit policies.
Intervention Type
Biological
Intervention Name(s)
Olive Oil Massage
Intervention Description
olive oil massage application.
Primary Outcome Measure Information:
Title
Rate of culture-proven sepsis in the blood or CSF
Description
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.
Time Frame
72 hours from birth till 28 days of life
Secondary Outcome Measure Information:
Title
Neonatal Skin Condition score
Description
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.
Time Frame
72 hours from birth till 28 days of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jubara Alallah
Phone
966554688775
Ext
28335
Email
AlallahJS@ngha.med.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jubara Alallah
Organizational Affiliation
King Abdulaziz Medical city , WR
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdulaziz Medical City
City
Jeddah
State/Province
WR
ZIP/Postal Code
21423
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jubara Alallah, MD
Phone
0122266666
Ext
22069
Email
alallahjs@ngha.med.sa
Facility Name
King Abdulaziz University Hospital
City
Jeddah
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saad Alsaedi

12. IPD Sharing Statement

Plan to Share IPD
No

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

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