Enteral Feeding of Premature Babies and Olive Oil Supplementation
The Effect of Enteral Organic Extra Virgin Olive Oil Supplementation in Premature Babies on Postnatal Growth and Premature Morbidities
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedJuly 15, 2024
July 1, 2024
1.3 years
September 13, 2023
July 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients who completed the study
To enrolment of 40 babies in the study in both groups
15 months
Postnatal growth retardation rates
Daily weight intake amounts of babies in both groups
18 months
Secondary Outcomes (1)
Frequency and severity of retinopathy of prematurity
18 months
Study Arms (2)
Olive oil group
ACTIVE COMPARATORBabies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil
Control group
NO INTERVENTIONInterventions
Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- Having a congenital or genetic anomaly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa City Hospital
Bursa, 16110, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Division of Neonatology, Associate Professor
Study Record Dates
First Submitted
September 13, 2023
First Posted
October 10, 2023
Study Start
October 1, 2023
Primary Completion
December 31, 2024
Study Completion
March 31, 2025
Last Updated
July 15, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share