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

Last updated: January 18, 2021
Sponsor: King Abdullah International Medical Research Center
Overall Status: Active - Recruiting

Phase

2/3

Condition

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT04717037
RJ20/109/J
  • Ages 24-32
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 neonatalsepsis, 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

Total Participants: 300
Study Start date:
September 01, 2020
Estimated Completion Date:
August 01, 2022

Connect with a study center

  • King Abdulaziz Medical City

    Jeddah, WR 21423
    Saudi Arabia

    Active - Recruiting

  • King Abdulaziz University Hospital

    Jeddah,
    Saudi Arabia

    Site Not Available

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