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

King Abdullah International Medical Research Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pre-Term; Late-Onset Neonatal Sepsis; Sepsis

Treatments: Biological: Olive Oil Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT04717037

RJ20/109/J

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 24 to 32 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Study

Experimental group

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 .

Treatment:

Biological: Olive Oil Massage

Control

No Intervention group

Description:

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