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Enteral Feeding of Premature Babies and Olive Oil Supplementation

Primary Purpose

Premature, Olive Oil, Enteral Feeding

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extra virgin organic olive oil (ULTRA PREMIUM)
Sponsored by
Bursa City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature

Eligibility Criteria

14 Days - 40 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Premature babies born at 32 weeks or less Babies who tolerate full enteral feeding at the before end of the second week Babies given consent by their parents - Exclusion Criteria: Having a congenital or genetic anomaly

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Olive oil group

    Control group

    Arm Description

    Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil

    Outcomes

    Primary Outcome Measures

    Number of patients who completed the study
    To enrolment of 40 babies in the study in both groups
    Postnatal growth retardation rates
    Daily weight intake amounts of babies in both groups

    Secondary Outcome Measures

    Frequency and severity of retinopathy of prematurity
    Frequency and severity of retinopathy of prematurity

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    October 2, 2023
    Sponsor
    Bursa City Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06072625
    Brief Title
    Enteral Feeding of Premature Babies and Olive Oil Supplementation
    Official Title
    The Effect of Enteral Organic Extra Virgin Olive Oil Supplementation in Premature Babies on Postnatal Growth and Premature Morbidities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    March 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bursa City Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding. Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values. Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature, Olive Oil, Enteral Feeding

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Olive oil group
    Arm Type
    Active Comparator
    Arm Description
    Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Extra virgin organic olive oil (ULTRA PREMIUM)
    Intervention Description
    Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil
    Primary Outcome Measure Information:
    Title
    Number of patients who completed the study
    Description
    To enrolment of 40 babies in the study in both groups
    Time Frame
    15 months
    Title
    Postnatal growth retardation rates
    Description
    Daily weight intake amounts of babies in both groups
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Frequency and severity of retinopathy of prematurity
    Description
    Frequency and severity of retinopathy of prematurity
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Days
    Maximum Age & Unit of Time
    40 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Premature babies born at 32 weeks or less Babies who tolerate full enteral feeding at the before end of the second week Babies given consent by their parents - Exclusion Criteria: Having a congenital or genetic anomaly
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayten Erdoğan Ordu, MD
    Phone
    +905389429336
    Email
    aytenli21@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Murat Tutanc, Prof
    Phone
    +905553803484
    Email
    drtutanc@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Enteral Feeding of Premature Babies and Olive Oil Supplementation

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