PrematureNCT06072625
Enteral Feeding of Premature Babies and Olive Oil Supplementation
A study testing Extra virgin organic olive oil (ULTRA PREMIUM) in people with Premature and Olive Oil, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 daysHealthy volunteers can take part
- Conditions the study is for
- Premature, Olive Oil, Enteral Feeding
- What is being tested?
- Extra virgin organic olive oil (ULTRA PREMIUM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 -
Who cannot join
- Having a congenital or genetic anomaly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, 16110
About this study
Official title: The Effect of Enteral Organic Extra Virgin Olive Oil Supplementation in Premature Babies on Postnatal Growth and Premature Morbidities
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.
- Conditions
- Premature, Olive Oil, Enteral Feeding
- Being tested
- Extra virgin organic olive oil (ULTRA PREMIUM)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra virgin organic olive oil (ULTRA PREMIUM)Dietary supplement
Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil
| Study group | Role | What they receive |
|---|---|---|
| Olive oil group | Active comparator | Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil Receives: Dietary Supplement: Extra virgin organic olive oil (ULTRA PREMIUM) |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who completed the study
To enrolment of 40 babies in the study in both groups
Measured: 15 months
Postnatal growth retardation rates
Daily weight intake amounts of babies in both groups
Measured: 18 months
Secondary outcomes (1)
Frequency and severity of retinopathy of prematurity
Frequency and severity of retinopathy of prematurity
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bayram Ali DORUM, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072625
- Sponsor's protocol ID
- BCH-2023-12/8
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dorum BA, Erdogan A, Cakir SC, Yarci E, Ozgur T, Unalli Ozmen S, Tutanc M. The Effect of Enteral Organic Extra Virgin Oil Supplementation in Premature Babies on Postnatal Growth, Premature Morbidities, and Oxidative Status. Children (Basel). 2026 Feb 26;13(3):327. doi: 10.3390/children13030327.
PubMed 41897040
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enteral Organic Extra Virgin Olive Oil Supplementation in Premature Babies on Postnatal Growth and Premature Morbidities
- ClinicalTrials.gov ID
- NCT06072625
- Acronym / sponsor ID
- BCH-2023-12/8
- Conditions
- Premature, Olive Oil, Enteral Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olive oil group | Active comparator | Dietary Supplement: Extra virgin organic olive oil (ULTRA PREMIUM)Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil |
| Control group | No intervention | – |
Who may qualify
- Ages
- 14 to 40 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (1 listed)
- Having a congenital or genetic anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra virgin organic olive oil (ULTRA PREMIUM)Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil | Dietary supplement | Olive oil group |
Primary outcome
Number of patients who completed the study
Time frame: 15 months
To enrolment of 40 babies in the study in both groups
Postnatal growth retardation rates
Time frame: 18 months
Daily weight intake amounts of babies in both groups
1 secondary outcome
Frequency and severity of retinopathy of prematurity
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 41897040Dorum BA, Erdogan A, Cakir SC, Yarci E, Ozgur T, Unalli Ozmen S, Tutanc M. The Effect of Enteral Organic Extra Virgin Oil Supplementation in Premature Babies on Postnatal Growth, Premature Morbidities, and Oxidative Status. Children (Basel). 2026 Feb 26;13(3):327. doi: 10.3390/children13030327.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra virgin organic olive oil (ULTRA PREMIUM) in people with Premature and Olive Oil, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayten Erdoğan Ordu, MD (+905389429336, aytenli21@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who completed the study (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.