SepsisPhase 2/3OMEPSNCT04717037
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)
A Phase 2/3 study testing Olive Oil Massage in people with Sepsis and Pre-Term, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Sepsis, Pre-Term, Late-Onset Neonatal Sepsis
- What is being tested?
- Olive Oil Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 1 Sep 2020to 1 Aug 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Abdulaziz Medical City
Jeddah, WR, 21423
Jubara Alallah, MD, 0122266666 ext. 22069, alallahjs@ngha.med.sa
- Not yet recruiting
King Abdulaziz University Hospital
Jeddah
Saad Alsaedi
About this study
Official title: 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.
- Conditions
- Sepsis, Pre-Term, Late-Onset Neonatal Sepsis
- Being tested
- Olive Oil Massage
- Keywords
- Olive oil, Massage, Preterm, Late-Onset sepsis
- Medical subject headings
- Sepsis, Premature Birth, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Oil MassageBiological
olive oil massage application.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | 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 . Receives: Biological: Olive Oil Massage |
| Control | No intervention | Patients who are assigned to the control group will receive standard care as per unit policies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours from birth till 28 days of life
Secondary outcomes (1)
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.
Measured: 72 hours from birth till 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Sep 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz University
- Responsible party
- Sponsor
- Investigators
- Jubara Alallah, Principal investigator, King Abdulaziz Medical city , WR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717037
- Sponsor's protocol ID
- RJ20/109/J
- Acronym
- OMEPS
- Status last verified
- Jan 2021
- First submitted
- 8 Dec 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS), Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04717037
- Acronym / sponsor ID
- OMEPS / RJ20/109/J
- Conditions
- Sepsis, Pre-Term, Late-Onset Neonatal Sepsis
- Keywords
- Olive oil, Massage, Preterm, Late-Onset sepsis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Collaborators
- King Abdulaziz University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Biological: Olive Oil MassageThe olive oil massage will be applied initially at 72 hrs of life then twice daily with a dose of 4ml/kg till 28 days . |
| Control | No intervention | –Patients who are assigned to the control group will receive standard care as per unit policies. |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive Oil Massageolive oil massage application. | Biological | Study |
Primary outcome
Rate of culture-proven sepsis in the blood or CSF
Time frame: 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.
1 secondary outcome
Neonatal Skin Condition score
Time frame: 72 hours from birth till 28 days of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jubara Alallah principal investigator
King Abdulaziz Medical city , WR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Olive Oil Massage in people with Sepsis and Pre-Term, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jubara Alallah (966554688775 ext. 28335, AlallahJS@ngha.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of culture-proven sepsis in the blood or CSF (time frame: 72 hours from birth till 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.