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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04717037

Acronym

OMEPS

Enrollment

300

Registered

2021-01-20

Start date

2020-09-01

Completion date

2022-08-01

Last updated

2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-Onset Neonatal Sepsis, Pre-Term, Sepsis

Keywords

Olive oil, Massage, Preterm, Late-Onset sepsis

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.

Interventions

BIOLOGICALOlive Oil Massage

olive oil massage application.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

24 Weeks to 32 Weeks

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Saudi Arabia

Contacts

Primary ContactJubara Alallah

AlallahJS@ngha.med.sa966554688775

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026