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

NCT04717037 | Unknown Phase 2 DMC

• 1 other identifier: RJ20/109/J
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Sepsis; Pre-Term; Late-Onset Neonatal Sepsis

Keywords

Olive oil; Massage; Preterm; Late-Onset sepsis

Outcome Measures

Primary Outcomes (1)

• Rate of culture-proven sepsis in the blood or CSF

  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.

  72 hours from birth till 28 days of life

Secondary Outcomes (1)

• Neonatal Skin Condition score

  72 hours from birth till 28 days of life

Study Arms (2)

Study

EXPERIMENTAL

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 .

Biological: Olive Oil Massage

Control

NO INTERVENTION

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

Interventions

Olive Oil Massage BIOLOGICAL

olive oil massage application.

Study

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead
• King Abdulaziz University: collaborator

Study Sites (2)

King Abdulaziz Medical City

Jeddah, WR, 21423, Saudi Arabia

RECRUITING

King Abdulaziz University Hospital

Jeddah, Saudi Arabia

NOT YET RECRUITING

MeSH Terms

Conditions

Sepsis; Premature Birth; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jubara Alallah

  King Abdulaziz Medical city , WR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jubara Alallah

CONTACT

966554688775; AlallahJS@ngha.med.sa

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: January 20, 2021
• Study Start: September 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)