Status:

UNKNOWN

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

Lead Sponsor:

King Abdullah International Medical Research Center

Collaborating Sponsors:

King Abdulaziz University

Conditions:

Sepsis

Pre-Term

Eligibility:

All Genders

24-32 years

Phase:

PHASE2

PHASE3

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2022

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT04717037

Start Date

September 1 2020

End Date

August 1 2022

Last Update

January 20 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

King Abdulaziz Medical City

Jeddah, WR, Saudi Arabia, 21423

2

King Abdulaziz University Hospital

Jeddah, Saudi Arabia