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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis Pre-Term Late-Onset Neonatal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study

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 .

Group Type EXPERIMENTAL

Olive Oil Massage

Intervention Type BIOLOGICAL

olive oil massage application.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Olive Oil Massage

olive oil massage application.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

24 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No